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A 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior effectiveness of the services at issue. The testing in dispute was ordered to determine the etiology for possible loss of response to Humira. The use of Anser ADA has not been clinically proven in controlled studies to improve patient clinical outcomes or to be more effective than conventional courses. Patients treated with Humira may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Clinical guidelines for management of inflammatory bowel disease do not recommend testing for anti-drug antibody during clinical management. Therefore, tumor necrosis factor antagonist testing performed on 4/04/15 was not likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
this patient had a long history of neurogenic claudication. He has failed conservative treatment for over six months, including nonsteroidal anti-inflammatory drugs, opioids, physical therapy, epidural steroid injections, and bracing. His provider has recommended minimally invasive interspinous process spacer using the Superion device. Nunley and colleagues | Upheld | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient had a long history of neurogenic claudication. He has failed conservative treatment for over six months, including nonsteroidal anti-inflammatory drugs, opioids, physical therapy, epidural steroid injections, and bracing. His provider has recommended minimally invasive interspinous process spacer using the Superion device. Nunley and colleagues presented a four-year follow-up of 89 patients who underwent the procedure for spinal stenosis. At four years after the procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success in terms of back and leg pain. The minimally invasive implantation procedure of the Superion device provided relief of symptoms of intermittent neurogenic claudication in these patients with moderate lumbar spinal stenosis. The second article referenced is a five-year follow-up and indicated that 75 percent of these patients continued to do well and did not require any other treatment such as an open decompression/fusion procedure. Thus, the requested surgical insertion of an interspinous process spacer is likely to be more beneficial than other available standard therapy.
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The parent of a 10-year-old male enrollee has requested authorization and coverage for Omnitrope (somatropin) injection 1.3 mg/day, six days per week. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has no evidence of poor growth on the growth chart. In fact, he went from the 5th to 10th percentile. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 10-year-old male enrollee has requested authorization and coverage for Omnitrope (somatropin) injection 1.3 mg/day, six days per week. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient has no evidence of poor growth on the growth chart. In fact, he went from the 5th to 10th percentile. The diagnosis of growth hormone deficiency without clinical evidence of poor linear growth cannot be supported. Accordingly to guidelines, there is not a single test to diagnose growth hormone deficiency. Although this patient failed the growth hormone stimulation test, in the absence of poor growth, this test alone cannot establish the diagnosis of growth hormone deficiency. This patient was pre-pubertal at 10 years of age. It is likely his growth rate will increase even more when he enters puberty. There is a lack of support for the requested medication in this clinical setting. Therefore, Omnitrope (somatropin) injection 1.3 mg per day, six days per week is not medically necessary for the treatment of this patient. | 1 |
A 30-year-old female enrollee has requested reimbursement for bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition.
that this patient presented with a longstanding history of bilateral severe hallux valgus deformity, left greater than right. She complained of pain with weight-bearing. Conservative treatment had included activity modification, bracing, wide shoes, and nonsteroidal anti-inflammatory drugs. She had a left hallux valgus angle (HVA) of 35 degrees, and intermetatarsal angle (IMA) of 15 degrees. She had a right HVA of 35 degrees, and intermetatarsal angle (IMA) of 18 degrees. She underwent left chevron osteotomy and modified McBride procedure with x-ray fluoroscopy on 6/10/19, and right scarf osteotomy and modified McBride procedure with x-ray fluoroscopy on 7/29/19. | Overturned | Experimental | Summary Reviewer 1
A 30-year-old female enrollee has requested reimbursement for bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presented with a longstanding history of bilateral severe hallux valgus deformity, left greater than right. She complained of pain with weight-bearing. Conservative treatment had included activity modification, bracing, wide shoes, and nonsteroidal anti-inflammatory drugs. She had a left hallux valgus angle (HVA) of 35 degrees, and intermetatarsal angle (IMA) of 15 degrees. She had a right HVA of 35 degrees, and intermetatarsal angle (IMA) of 18 degrees. She underwent left chevron osteotomy and modified McBride procedure with x-ray fluoroscopy on 6/10/19, and right scarf osteotomy and modified McBride procedure with x-ray fluoroscopy on 7/29/19. Current evidence-based medical literature supports the use of surgical treatment of hallux valgus in this clinical setting, given the severity of the HVA and IMR angles, significant pain and functional impairment, and failure of non-operative treatment. Additionally, there is no indication in the literature to support ongoing conservative treatment over surgical correction in the setting of severe deformity. Therefore, bony correction bunionectomy to treat symptomatic hallux valgus performed on 6/10/19 and 7/29/19 was likely to have been more beneficial than other treatment options.
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A 19-year-old female enrollee has requested reimbursement for electromyography (EMG) and electroencephalogram (EEG) monitoring during spine surgery performed on 12/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 3
A 19-year-old female enrollee has requested reimbursement for electromyography (EMG) and electroencephalogram (EEG) monitoring during spine surgery performed on 12/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that in spinal deformity corrective operations, the use of intraoperative neurophysiologic monitoring has become standard of the care. The medical literature has shown the beneficial effects of this type of intraoperative monitoring. This type of monitoring has been helpful in avoiding potential catastrophic neurologic injury and allows the surgeons to be vigilant and to be able to reverse neurophysiological changes. This modality may prevent catastrophic permanent neurologic injury. Therefore, EMG and EEG monitoring during spine surgery performed on 12/05/19 was likely to have been more beneficial than other available standard therapy.
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A 59-year-old female enrollee has requested reimbursement for Foundation One CDX testing performed on 11/23/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for Foundation One CDX testing performed on 11/23/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that understanding the molecular drivers of cancer progression and metastases is an area of ongoing and active research, predominantly driven by the goal of identifying specific genomic aberrations that may ultimately result in individualized cancer treatment. In addition to likely providing prognostic information, the value of next generation sequencing to predict candidates for specific mutation-driven treatment holds promise, but is not yet ready for routine clinical use. Although the ability to decipher genomic aberrations in individual breast cancers to the single nucleotide resolution is now possible, there is a lack of data to show that this information can guide treatment decisions for patients with metastatic breast cancer. The use of next generation sequencing, such as with FoundationOne CDx testing, continues to be the subject of ongoing clinical trials. Therefore, FoundationOne CDx performed on 11/23/18 was not medically necessary for the evaluation of this patient. | 0 |
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. | Overturned | Experimental | Summary Reviewer 2
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found there is sufficient support for the service at issue in this clinical setting. According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, the literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. Therefore, digital breast tomosynthesis performed on 7/06/16 was likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
the patient has a long history of lower extremity lymphedema secondary to treatment for cervical cancer. The patients therapy has consisted of compression devices and a short term of decongestive therapy. This has had significant functional effect on her life as she has been unable to resume her normal physical activity and has had six episodes of lower extremity cellulitis. | Overturned | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient has a long history of lower extremity lymphedema secondary to treatment for cervical cancer. The patients therapy has consisted of compression devices and a short term of decongestive therapy. This has had significant functional effect on her life as she has been unable to resume her normal physical activity and has had six episodes of lower extremity cellulitis. Vascularized lymph node transfer has demonstrated significant benefit in multiple case series to reduce the extent of lymphedema and increase quality of life. While there is a lack of prospective comparison trials, the results of the multiple single center case series are compelling and are sufficient to demonstrate an anticipated benefit for this patient. Therefore, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 17-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 10/24/18 through discharge. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
. The medical records indicate that the patient was not actively suicidal. The progress notes indicate that the patient was not engaging in self-harm behaviors or expressing suicidal ideation. She did have a history of suicidal ideation.
2. The patient had some issues with level of function, but the progress notes indicate significant improvement after a period of deterioration as evidenced by appropriate activities of daily living and grooming as well as therapy participation.
. The patient did not have active medical problems, and she reported a history substance use with several substances. She did not describe continued cravings, and there was no documentation of withdrawal symptoms.
The patient was noted to have interpersonal conflict with the family as a focus of treatment.
. The patients mother was involved in treatment on a regular basis.
history, the records support a score of 3. The patient had a good response to a short period in the residential
center prior to the disputed dates. Her presentation during the disputed timeframe indicates that she was cooperative in treatment. In terms of
and engagement of the patient, the records support a score of 2. The patient actively participated in therapy, and she was able to develop a positive relationship with clinicians. With regards to | Upheld | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 10/24/18 through discharge. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2. The medical records indicate that the patient was not actively suicidal. The progress notes indicate that the patient was not engaging in self-harm behaviors or expressing suicidal ideation. She did have a history of suicidal ideation. With regards to functional status, the records support a score of 2. The patient had some issues with level of function, but the progress notes indicate significant improvement after a period of deterioration as evidenced by appropriate activities of daily living and grooming as well as therapy participation. In terms of comorbidity, the records support a score of 2. The patient did not have active medical problems, and she reported a history substance use with several substances. She did not describe continued cravings, and there was no documentation of withdrawal symptoms. With regards to level of stress of the recovery environment, the records support a score of 2. The patient was noted to have interpersonal conflict with the family as a focus of treatment. However, the progress notes document that her family therapy sessions were productive and not adversarial. In terms of level of support of the recovery environment, the records support a score of 2. The patients mother was involved in treatment on a regular basis. With regards to resiliency and treatment history, the records support a score of 3. The patient had a good response to a short period in the residential treatment center prior to the disputed dates. Her presentation during the disputed timeframe indicates that she was cooperative in treatment. In terms of acceptance and engagement of the patient, the records support a score of 2. The patient actively participated in therapy, and she was able to develop a positive relationship with clinicians. With regards to acceptance and engagement of the parent, the records support a score of 2. The patients parent worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 17. This score correlates with intensive outpatient services. Therefore, residential mental health treatment for children and adolescents provided from 10/24/18 through 11/02/18 was not medically necessary for the treatment of this patient. | 1 |
A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx-Melanoma Gene Assay assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. According to the results of analysis of this patients DecisionDx-Melanoma Gene Assay testing, the tumor was classified as Class 2A with molecular signature associated with a high risk of near term (within five years) metastatic disease, such as 77% recurrence and 80% distant metastasis free rates. Identification of the increased risk of recurrence of melanoma in this patient helped establishing appropriate follow up plan to improve the outcome in this particular patient. Thus, the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 46-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a.
In this case, the patient has hepatitis C without evidence of cirrhosis on liver biopsy in 2011 or ultrasound in | Overturned | Medical Necessity | Summary Reviewer
A 46-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C virus, regardless of fibrosis, should be treated except those with a life expectancy of less than 12 months due to non-liver-related comorbid conditions. This recommendation is based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. Moreover, it is beneficial to treat patients with hepatitis C before they progress to F3 or F4 fibrosis. In this case, the patient has hepatitis C without evidence of cirrhosis on liver biopsy in 2011 or ultrasound in 2015. Although FibroScan in 2015 was consistent with cirrhosis, the patients aspartate-to-platelet ratio index (APRI) based labs on that date were not consistent with advanced fibrosis or cirrhosis. Therefore, the 12 week therapy recommendation should apply, rather than the 24 week duration recommended for patients with cirrhosis. Thus, a 12 week course of Harvoni is supported as medically necessary for treatment of this patients hepatitis C virus. In conclusion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 63-year-old male enrollee has requested authorization and coverage for transcatheter radiofrequency ablation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees paroxysmal atrial fibrillation. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested authorization and coverage for transcatheter radiofrequency ablation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees paroxysmal atrial fibrillation. The physician reviewer found the guidelines from the Heart Rhythm Society give a Class I recommendation for ablation if the patient has failed at least one Type I or Type III anti-arrhythmic medication. This patients records do not document that he has been treated with a medication that meets these criteria. Trial of such medication might require use of a permanent pacemaker or close electrocardiography monitoring while on a medication trial to see if the patients bradycardia is worsened. The guidelines also state that a patient with a high congestive heart failure, hypertension, age, diabetes mellitus, and prior stroke (CHADS) score would need to stay on long-term anti-coagulants for stroke prevention even after successful ablation. All told, this patient has not met the established criteria for medication trial, and thus the requested transcatheter radiofrequency ablation is not supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 58-year-old female who was evaluated in the emergency department on 12/22/19. The patient has requested reimbursement for emergency room physician services provided on 12/22/19. The Health Insurer has denied this request and reported that the services at issue were not required on an emergent basis.
This patient presented with the sudden onset of low back pain. There was no recent trauma, and the patient did not have a history of low back pain. She had tried over-the-counter pain medication, without relief. Her symptoms continued to worsen over the course of the next day. The patientas lumbar CT scan and MRI revealed multilevel degenerative changes. Despite intravenous pain medication, the patient was still unable to ambulate and was unable to be discharged. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 58-year-old female who was evaluated in the emergency department on 12/22/19. The patient has requested reimbursement for emergency room physician services provided on 12/22/19. The Health Insurer has denied this request and reported that the services at issue were not required on an emergent basis. The physician reviewer found that at issue in this case is whether a prudent layperson in the patientas circumstances would believe he or she was experiencing an emergency medical condition. California law defines an aemergency medical conditiona as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patientas health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. This patient presented with the sudden onset of low back pain. There was no recent trauma, and the patient did not have a history of low back pain. She had tried over-the-counter pain medication, without relief. Her symptoms continued to worsen over the course of the next day. The patientas lumbar CT scan and MRI revealed multilevel degenerative changes. Despite intravenous pain medication, the patient was still unable to ambulate and was unable to be discharged. The sudden onset of severe low back pain that does not respond to over-the-counter pain medication with the inability to ambulate meets prudent layperson criteria for an emergency. A prudent layperson in these circumstances would reasonably expect the absence of emergency care to jeopardize her health. Therefore, this patientas symptoms on 12/22/19 met prudent layperson criteria for emergency care. | 1 |
A 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patients family history is suggestive of a breast/ovarian cancer syndrome. BRCA1 mutation can increase risk for breast, ovarian, cervical, uterine, pancreatic, gastric, and prostate cancers. BRCA2 mutations can increase risk for breast, ovarian, gallbladder, bile duct, prostate, pancreatic, and gastric cancers. In the event the BRCA tests were negative, there is still a possibility of hereditary predisposition from another gene defect. There are guidelines in place that evaluate the occurrence of Lynch syndrome or hereditary nonpolyposis colorectal cancer tumors in families. The most common extracolonic cancer in Lynch syndrome is endometrial cancer followed, in no particular order, by ovarian, gastric, renal, small intestine, pancreas, hepatobiliary, and ureteral. The MyRisk panel is appropriate since the current clinical situation may be caused by several potential cancer-causing genes. Thus, testing for cancer risk using panels of genes (MyRisk) provided on 6/05/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. | Upheld | Experimental | Summary Reviewer 3
A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Sheu and Rattner concluded that the long-term safety and efficacy of LINX remains to be determined. Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval. Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention. The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication. Thus, the LINX Reflux Management System is not likely to be more effective than other treatment alternatives. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain.
, the patient previously underwent lumbar medial branch blocks and lumbar RFA in the past. The records indicate that the patient underwent lumbar medial branch blocks successfully and then underwent lumbar RFA. The prior RFA provided over one year of pain relief. | Overturned | Experimental | Summary Reviewer 1
A 42-year-old male enrollee has requested authorization and coverage for radiofrequency neurolysis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back and left lower extremity pain. The physician reviewer found according to the providers notes, the patient previously underwent lumbar medial branch blocks and lumbar RFA in the past. The records indicate that the patient underwent lumbar medial branch blocks successfully and then underwent lumbar RFA. The prior RFA provided over one year of pain relief. Given this patients treatment history, repeated lumbar medial branch blocks are not needed prior to repeat RFA. Therefore, the requested RFA is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 48-year-old female enrollee has requested authorization and coverage for reconstructive lymphedema surgeries and one (1) inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 48-year-old female enrollee has requested authorization and coverage for reconstructive lymphedema surgeries and one (1) inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrolleeas condition than any available standard therapy. The physician reviewer found that
there is sufficient support for the requested services in this clinical setting. Chang and colleagues noted, aMany studies seem to support some efficacy of lymphovenous bypass and vascular lymph node transfer.a Beederman and colleagues followed 274 patient and reported, aPatients with secondary upper or lower extremity lymphedema who undergo vascularized lymph node transplant/lymphovenous bypass demonstrate improved functional status and reduced affected limb volumes postoperatively. Patients with upper extremity lymphedema appear to have a more substantial reduction in limb volume differential compared to lower extremity lymphedema patients.a Coriddi and colleagues noted, aPhysiologic surgical treatment of lymphedema results in improved quality of life outcomes in most patients.a Based on the literature, lymphaticovenous anastomosis and vascularized lymph node transfer offer benefits to patients who have undergone extensive attempts at decongestive therapy and still have significant lymphedema. The patient is noted to be compliant with her therapy. Therefore, reconstructive lymphedema surgeries and one (1) inpatient bed day are likely to be more beneficial than other available standard therapy.
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A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia. | Upheld | Experimental | Summary Reviewer 2
A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia. The physician reviewer found that the procedure (neurolysis) at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of large, scientific, randomized, controlled studies showing the long-term effectiveness of neurolysis in this clinical setting. There are some promising studies supporting neurolysis of the greater occipital nerve (Ducic, et al; Acar, et al). However, these studies are primarily retrospective, small, uncontrolled studies with only short-term follow up. Given the lack of sufficient support in the peer-reviewed literature, the decompression procedure performed on 10/5/15 has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the procedure at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea. | Upheld | Experimental | Summary Reviewer 2
A 24-year-old female enrollee has requested reimbursement for 83993 (fecal calprotectin) provided on 1/30/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of diarrhea. The physician reviewer found that persistent disease activity is associated with a poor prognosis in inflammatory bowel disease. Therefore, monitoring of patients with intent to suppress subclinical inflammation has emerged as a reasonable community-standard treatment goal. As endoscopic monitoring is invasive, identification of valid markers of disease activity has been a priority. Fecal calprotectin testing is commonly used in clinical practice to differentiate between non-organic and inflammatory intestinal disorders, especially to identify inflammatory bowel disease. Fecal calprotectin may also be useful to monitor patients with inflammatory bowel disease under treatment and to predict the risk of recurrence of active disease prior to clinical relapse. In this patients case, the provider noted that fecal calprotectin testing was recommended to distinguish inflammatory from noninflammatory diarrhea. However, prior stool and imaging studies were negative, and inflammatory bowel disease was an unlikely possibility based on the history. While fecal calprotectin as commonly employed in clinical practice may have value in irritable bowel disease patients, or even in cases of diagnostic uncertainty, this testing was not supported in this patients case. In sum, the superior efficacy of 83993 (fecal calprotectin) provided on 1/30/18 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program treatment provided from 9/22/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
In this case, the patient has been diagnosed with major depressive disorder, recurrent, generalized anxiety disorder, bulimia nervosa in partial remission and obsessive compulsive disorder and has completed a month long residential DBT program due to the long history of self-injurious behavior and suicide attempts. She engaged in the treatment however she still continues to have significant symptoms of depression and anxiety. Per the therapy note dated 9/28/15 the patient reported feeling an increase of anxiety due to multiple transitions over the last year. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program treatment provided from 9/22/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that mental health intensive outpatient program treatment provided from 9/22/15 forward was and is medically necessary for treatment of the patients medical condition. According to the American Psychiatric Association guidelines services available for the treatment of eating disorders can range from intensive inpatient settings to residential and partial hospitalization programs to varying levels of outpatient care. In this case, the patient has been diagnosed with major depressive disorder, recurrent, generalized anxiety disorder, bulimia nervosa in partial remission and obsessive compulsive disorder and has completed a month long residential DBT program due to the long history of self-injurious behavior and suicide attempts. She engaged in the treatment however she still continues to have significant symptoms of depression and anxiety. Per the therapy note dated 9/28/15 the patient reported feeling an increase of anxiety due to multiple transitions over the last year. Based on the documentation submitted for review, the request for intensive outpatient program treatment provided from 9/22/15 forward was and is medically necessary as this patient continues to have significant symptoms of depression and anxiety. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 20-year-old female enrollee has requested reimbursement for acute inpatient psychiatric treatment from 9/15/15 through 11/8/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition
By 9/15/15, the patient was not a danger to herself or others. She was not aggressive or violent. She denied and did not demonstrate self-harm or eating disorder urges. She was cognitively intact and she was not gravely disabled. She was cooperative and participating in her treatment plan. Through the balance of her stay she remained overall euthymic with bright affect. Although nursing assessments reported her as delusional, this was not described and
. For most of her hospitalization leading up to the dates in dispute, she was described as euthymic with congruent affect. Her behavior had stabilized and | Upheld | Medical Necessity | Summary Reviewer
A 20-year-old female enrollee has requested reimbursement for acute inpatient psychiatric treatment from 9/15/15 through 11/8/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. By 9/15/15, the patient was not a danger to herself or others. She was not aggressive or violent. She denied and did not demonstrate self-harm or eating disorder urges. She was cognitively intact and she was not gravely disabled. She was cooperative and participating in her treatment plan. Through the balance of her stay she remained overall euthymic with bright affect. Although nursing assessments reported her as delusional, this was not described and no auditory or visual hallucinations were endorsed. For most of her hospitalization leading up to the dates in dispute, she was described as euthymic with congruent affect. Her behavior had stabilized and there was no evidence that stepping her down to a lower level of care would have resulted in immediate acute inpatient re-hospitalization. She tolerated medication changes without incident. At this point, she did not require 24-hour a day, seven days a week supervision. She could have safely continued treatment at an ambulatory level of care such as partial hospitalization program. As such, acute inpatient psychiatric treatment services from 9/15/15 through 11/8/15, were not medically necessary. Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. | Overturned | Experimental | Summary Reviewer 2
A 66-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 8/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees lung adenocarcinoma. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection beyond standard testing, such as EGFR. The National Comprehensive Cancer Network guidelines advise broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with non-small cell lung cancer. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. In sum, Guardant360 testing performed on 8/10/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of an 11-year-old female enrollee has requested authorization and coverage for Nutropin AQ Nuspin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. | Upheld | Medical Necessity | Summary Reviewer
The parent of an 11-year-old female enrollee has requested authorization and coverage for Nutropin AQ Nuspin. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the requested medication is not medically necessary for treatment of the patients medical condition. There is insufficient medical information in the submitted material to support medical necessity of GH treatment. If the patients diagnosis is intrauterine growth retardation with failure to catch up in height by age three, then data on birth weight and height, as well as a longitudinal growth chart from infancy until the start date of GH therapy should be provided. Based on the growth chart included for review, the patients height was within normal limits for age at age seven years from the 25th to 50th percentile. Thus, there is a lack of evidence that she had short stature warranting GH treatment at that time, although it is unclear if GH was started prior to that time and if there was a prior fall-off in growth. Additional information documenting abnormal results on provocative GH testing, pre-treatment height and weight, complete longitudinal growth curve dating back to the time before GH therapy was initiated, pre-treatment insulin-like growth factor-1 (IGF-1) level and results of other tests to rule out systemic causes of poor growth, were not provided to support the resumption of GH. As such, Nutropin AQ Nuspin has not been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 53-year-old male enrollee has requested reimbursement for the bronchial thermoplasty provided from 1/21/15 through 4/8/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees persistent asthma. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old male enrollee has requested reimbursement for the bronchial thermoplasty provided from 1/21/15 through 4/8/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees persistent asthma. The physician reviewer found that three initial trials of bronchial thermoplasty have demonstrated improved symptom control after the procedure was completed. Cox and colleagues reported on the AIR trial, which examined 112 patients with moderate-to-severe asthma and demonstrated improved control over the course of the one year follow-up. Pavord and colleagues conducted the RISA study and examined the safety of thermoplasty. The authors found short-term worsening in symptoms, but evidence of improved long-term control of asthma. Castro and colleagues reported on the AIR2 trial, which compared thermoplasty with a sham procedure and followed the patients for 12 months as well. The patients in this study had milder asthma when compared with the AIR and RISA study, with far fewer on oral corticosteroids. Several years ago, two follow-up studies were performed establishing a long-term improvement in asthma control over five years after the bronchial thermoplasty was performed. A follow-up of 14 patients in the RISA trial by Pavord and colleagues found a decrease in emergency department visits and hospitalizations in each year after bronchial thermoplasty and no change in lung function. The follow-up of the AIR2 trial from Wechsler and colleagues showed sustained improvement in 162 of the 190 patients followed for the complete five years. As with the RISA data, this was manifested with fewer emergency department visits and hospital admissions with stable spirometry and a decrease in mean inhaled steroid use over that period of time. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the medical literature supports the services at issue in this patients case. According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. All told, breast tomosynthesis performed on 7/21/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 60-year-old male enrollee has requested reimbursement for platelet-rich plasma injections performed on 3/11/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees plantar fasciitis. | Upheld | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested reimbursement for platelet-rich plasma injections performed on 3/11/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees plantar fasciitis. The physician reviewer found that the current medical evidence has not established the superior efficacy of the services at issue. The literature suggests that platelet-rich plasma injections are as effective as corticosteroids. Per Gogna and colleagues, when compared to low dose radiation, platelet-rich plasma injections were only seen to be as good. Platelet-rich plasma injections may be appropriate when corticosteroid and electric shock wave treatment therapies are performed and failed. Thus, platelet-rich plasma injections performed on 3/11/16 were not likely to have been more efficacious than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 19-year-old female with anorexia nervosa, post-traumatic stress disorder, major depressive disorder, and generalized anxiety disorder. She was admitted to a residential treatment center on 12/23/19.
The records noted a past history of multiple suicide attempts, and she expressed suicidal ideation at the residential treatment center.
records noted
moderate impairment due to troubled relationships with parents and lack of employment or school attendance prior to | Overturned | Medical Necessity | Summary Reviewer
The patient is a 19-year-old female with anorexia nervosa, post-traumatic stress disorder, major depressive disorder, and generalized anxiety disorder. She was admitted to a residential treatment center on 12/23/19. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) is a beneficial tool in determining the appropriate level of care. With regards to risk of harm, the records support a score of 4. The records noted a past history of multiple suicide attempts, and she expressed suicidal ideation at the residential treatment center. In terms of functional status, the records support a score of 3. The records noted
moderate impairment due to troubled relationships with parents and lack of employment or school attendance prior to admission. With regard to comorbidity, the records support a score of 3 due to the physical manifestations of anorexia nervosa, including low weight and laboratory abnormalities, co-occurring with post-traumatic stress disorder, depression, and anxiety symptoms. In terms of level of stress of the recovery environment, the records support a score of 3 due to discord with parents and recent transition back to the United States after a year of living abroad. With regard to level of support of the recovery environment, the records support a score of 3 due to parents ambivalence toward participating in treatment and lack of recent contact with the patient. In terms of treatment and recovery history, the records support a score of 4 due to the persistence of symptoms despite prior extensive treatment. With regard to engagement and recovery status, the records support a score of 3 due to poor insight and limited judgment. Thus, the patient has a composite score of 23. In this case, the records support medically monitored residential services. Therefore, eating disorder residential treatment center services from 1/23/20 forward were and are medically necessary for the treatment of this patient.
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A 53-year-old male has requested reimbursement for bronchial thermoplasty performed on 4/08/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old male has requested reimbursement for bronchial thermoplasty performed on 4/08/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence fails to demonstrate the medical necessity of the services at issue. Bronchial thermoplasty is a procedure that uses a bronchoscope probe/catheter to provide thermal energy to the smooth muscle of the airway. There are three bronchoscopic procedures. The first procedure treats the right lower lobe. The second procedure treats the left lower lobe, and the third bronchoscopic procedure is for both upper lobes. The procedures are scheduled three weeks apart. Bronchial thermoplasty is not generally accepted, standard of care for the treatment of asthma. The appeal letter states the patient has a progressive decrease in the quality of life. However, the available evidence does not demonstrate that bronchial thermoplasty would improve the long-term functional outcome of the patients condition. All told, bronchial thermoplasty performed on 4/08/15 was not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee. | Upheld | Experimental | Summary Reviewer 1
A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee. The physician reviewer found that Temporomandibular joint disorders
usually present with symptoms and signs such as pain, mandibular movement, dysfunction, or
joint sounds. Bruxism is characterized by teeth grinding. Botulinum toxin A (Botox) is a biologic
toxin which inhibits skeletal muscle through hindering the production of acetylcholine in the
nerve endings. The use of Botox for treatment of temporomandibular joint disorders and bruxism
is not consistent with U.S. Food and Drug Administration (FDA) indications. While there are
reports of the clinical use of Botox for the treatment of temporomandibular joint disorders and
bruxism, the clinical evidence in current medical literature is insufficient to demonstrate the
clinical efficacy of Botox in the treatment of temporomandibular joint disorders and bruxism or
that it is more beneficial than standard therapies including the use of occlusal devices, NSAIDs,
and physical therapy. Therefore, Botox is not likely to be more beneficial for treatment of the
patients condition than any available standard therapy.
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A 60-year-old female enrollee has requested authorization and coverage for percutaneous or
endoscopic spinal surgery. The Health Insurer has denied this request and reported that the
requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested authorization and coverage for percutaneous or
endoscopic spinal surgery. The Health Insurer has denied this request and reported that the
requested services are investigational for the treatment of the enrollees medical condition.
The physician reviewer found that a clear majority of current quality studies support MILD in
appropriately indicated patients. Jain and colleagues performed a review of 13 clinical studies,
including two randomized controlled trials. The authors noted statistically significant
improvement in pain and mobility, and superiority of MILD versus epidural steroid injections. In the multicenter study by Chopko, patients demonstrated a statistically significant reduction of pain
and statistically significant improvement in physical function and mobility from baseline through
two years. A randomized controlled clinical study by Staats and colleagues showed excellent
durability of the MILD procedure out to two years. All efficacy outcomes achieved significant
improvement from baseline to all follow-up intervals through two years. There was no evidence
of spinal instability at two years after the MILD procedure. According to the authors, MILD
demonstrated lower re-operation rates, less morbidity and greater safety when compared to the
broad range of lumbar spine interventions, including spacers, surgical decompression, and spinal
fusion. In a retrospective study by Mekhail, and colleagues, subjects experienced statistically
significant pain relief and reduction of opioid medications utilization at 3, 6, and 12 months
compared to baseline. MILD was also shown to be durable with only 9 out of 75 patients requiring
lumbar surgical decompression during the five-year follow-up period. MILD has been shown to
be a safe and effective procedure. There is sufficient support for the requested services in this
clinical setting. Therefore, percutaneous or endoscopic spinal surgery is likely to be more
beneficial than any available standard therapy.
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The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
ediatrician did make a diagnosis of chronic fatigue syndrome. The patient was subsequently given a clinical diagnosis of Lyme disease. He was prescribed oral and parenteral antibiotics in the absence of any evidence of an infection. | Upheld | Experimental | Summary Reviewer 3
The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found this patient has a history of a fatiguing illness. The etiology is not clear although one pediatrician did make a diagnosis of chronic fatigue syndrome. The patient was subsequently given a clinical diagnosis of Lyme disease. He was prescribed oral and parenteral antibiotics in the absence of any evidence of an infection. The period of therapy was also extended past the recommended duration. It is well-established that a maximum of 28 days is needed to treat late Lyme disease. Thus, intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015 was not likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). | Overturned | Experimental | Summary Reviewer 1
The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the testing at issue was likely to be more effective for this patient than other available treatment options. Chromosomal microarray analysis (CMA) is recommended by the American College of Medical Genetics (ACMG) as a first-tier test for patients with ASD (Manning and Hudgins). The yield of CMA in patients with ASD is estimated to be around 10 percent. While findings on CMA may not alter treatment of ASD features themselves in all patients, CMA has become the standard of care for diagnosis in patients with ASD. Increasing numbers of patients with ASD have been found to have underlying copy number variations. As such, it is possible that some copy number variations have also been associated with specific neuropsychological treatments or medications that have been shown to be more efficacious in patients with ASD due to that underlying cause. Additionally, copy number variations on CMA may inform about possible other complications and medical risks, some of which can be screened for and treated. For the reasons provided, FirstStep Dx Plus testing performed on 5/28/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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patient is a 14-year-old female who presented to her provider on 3/2/23. The records noted a
diagnosis of absence epilepsy and intractable epilepsy.
In this case, the patient has a history of absence epilepsy that has proven to be refractory to
conventional first-line therapies. The records note that Depakote therapy was associated with
pancreatitis, which | Overturned | Medical Necessity | Summary
The patient is a 14-year-old female who presented to her provider on 3/2/23. The records noted a
diagnosis of absence epilepsy and intractable epilepsy. The physician reviewer found that at issue is
whether the requested rufinamide 400 mg tablet #180/30 days is medically necessary for the treatment
of this patient. The submitted documentation supports the medical necessity of the requested
medication. In this case, the patient has a history of absence epilepsy that has proven to be refractory to
conventional first-line therapies. The records note that Depakote therapy was associated with
pancreatitis, which precludes a retrial. As newer anti-epileptic drugs have emerged, with different
mechanisms of action, epileptologists are faced with balancing best practices based on available drug
trials and emerging clinical experience with side effects. Besag and colleagues note that evidence from
randomized, double-blind, placebo-controlled trials supports the use of rufinamide as adjunct treatment
for drop seizures for patients with Lennox-Gastaut syndrome (LGS). While the patient in this case does
not have a diagnosis of LGS, the records document an associated epilepsy which has left her with a poor
quality of life and limited choices. Panebianco and colleagues report that for people with drug-resistant
focal epilepsy, rufinamide when used as an add-on treatment is effective in reducing seizure frequency.
In this clinical setting, while not without its own host of side effects, given that rufinamide may reduce
this patients seizure burden and provide her with a reasonable quality of life, the requested medication
is medically indicated. Therefore, rufinamide 400 mg tablet #180/30 days is medically necessary for the
treatment of this patient. | 1 |
The parent of a nine-year-old female enrollee has requested reimbursement for a dental expander. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dental condition.
documentation indicates that the patient was treated with a palatal expander due to a narrow upper arch with crowding and description of a unilateral crossbite. | Upheld | Medical Necessity | Summary Reviewer
The parent of a nine-year-old female enrollee has requested reimbursement for a dental expander. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees dental condition. The physician reviewer found There is a lack of support for the services at issue in this clinical setting. The documentation indicates that the patient was treated with a palatal expander due to a narrow upper arch with crowding and description of a unilateral crossbite. While the handicapping labio-lingual deviation index was 27, the method of scoring was questionable. There is no documentation provided to corroborate this score, and the scoring does not appear congruous with the limited case notes provided. The records included no preoperative work-up other than the handicapping labio-lingual deviation index score, which may have been calculated retrospectively. The literature does not have a consensus on whether interceptive treatment is always necessary, relying on variables such as whether the crossbite observed is unilateral or bilateral, whether that noted is a true unilateral crossbite or caused by a variation in the path of closing, and the degree of crossbite. The submitted records fail to demonstrate the medically necessity of the services at issue in this patients case. All told, the dental expander was not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 49-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of atrial septal defect. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 49-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of atrial septal defect. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the request for closure of PFO is not likely to be more effective for this patient than other available options. Studies to date have not shown a clear benefit of transcatheter closure of PFO compared to standard medical therapy. Observational studies from a single institution, non-randomized, suggest some benefit (Inglessis, et al). In sum, there is a lack of sufficient data to support the request for percutaneous transcatheter closure of atrial septal defect for this patient at this patient at this time. Based upon the information set forth above, the services at issue are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 37-year-old female enrollee has requested reimbursement for gene testing performed on 1/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found while fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign. The Afirma test utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on fine needle aspiration biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. All told, gene testing performed on 1/19/15 was likely to have been superior over other methods of evaluation. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 57-year-old male who presented to the emergency department of Mercy Medical Center in Redding, California with complaints of nausea, vomiting, decreased oral intake and epigastric abdominal pain radiating to the back. The patient has requested reimbursement for air ambulance transport provided on 10/16/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
individual is transported to the nearest hospital with appropriate facilities for treatment; | Overturned | Medical Necessity | Summary Reviewer
The patient is a 57-year-old male who presented to the emergency department of Mercy Medical Center in Redding, California with complaints of nausea, vomiting, decreased oral intake and epigastric abdominal pain radiating to the back. The patient has requested reimbursement for air ambulance transport provided on 10/16/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that in order for air medical transport to be medically necessary, all medical necessity criteria must be met. These criteria include: the patientas condition must be such that any form of transportation other than ambulance would be medically contraindicated; the individualas condition is such that time needed to transport by ground poses a threat to the patientas survival; the individual is transported to the nearest hospital with appropriate facilities for treatment; and there is a medical condition that is life-threatening. When transporting from one facility to another, the above criteria must be met, and the first hospital does not have the required services and facilities to treat the patient. Per the submitted documentation, this patient required an ERCP. Mercy Medical Center did not have gastroenterology services available to perform an ERCP. The documentation noted that California Pacific Medical Center a Van Ness was the closest facility with available gastrointestinal services. Time for ground transportation was at minimum 3 hours and 37 minute via a toll road. Generally, ground transport times greater than 30 minutes would justify the initiation of air transport. Transport by air took 1 hour and 28 minutes. There is sufficient support for air ambulance transport in this case. Therefore, air ambulance transport provided on 10/16/20 was medically necessary for the treatment of this patient.
| 1 |
The patient is a 59-year-old female who is diagnosed with uterine leiomyosarcoma. She was initially diagnosed at age 43 with stage I disease that recurred 15 years later. She was treated with doxorubicin and an anti-PDGFA antibody. A sample of the tumor was submitted for FoundationOne mutational analysis. The patient has requested reimbursement for the FoundationOne test performed on 11/14/16. The Health Insurer has denied this requested and reported that the services at issue were investigational for the evaluation of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 59-year-old female who is diagnosed with uterine leiomyosarcoma. She was initially diagnosed at age 43 with stage I disease that recurred 15 years later. She was treated with doxorubicin and an anti-PDGFA antibody. A sample of the tumor was submitted for FoundationOne mutational analysis. The patient has requested reimbursement for the FoundationOne test performed on 11/14/16. The Health Insurer has denied this requested and reported that the services at issue were investigational for the evaluation of this patients medical condition. The FoundationOne test is Clinical Laboratory Improvement Amendments (CLIA) approved for use on clinical specimens. It is a next generation test that analyzes for mutations or rearrangements in approximately 400 oncogenes and tumor suppressor genes. A study by Von Hoff and colleagues involved 86 patients where the progression free survival (PFS) on the regimen selected by molecular profiling was compared to the PFS on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. There are many parallels in the molecular genetics between soft tissue sarcomas and hematologic malignancies. For example, dermatofibrosis protuberans is characterized by recurrent translocation involving PDGFB, which may be targeted by imatinib. There is support in the medical literature for the use of genetic testing to identify mutations that may be amenable to targeted therapies. As such, the FoundationOne test performed on 11/14/16 was likely to have been more effective than the standard techniques available for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be overturned.
| 1 |
A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 52-year-old male enrollee has requested reimbursement for optical endomicroscopy performed on 5/30/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is some support for the services at issue in this clinical setting. Eluri and colleagues noted confocal laser endomicroscopy (CLE) can increase the yield of dysplasia detection with good accuracy compared with random biopsies. Wang and colleagues noted the use of CLE as a complementary tool during the endoscopic evaluation of Barretts esophagus was strongly supported by the panelists. In this case, the finding of nodule with dysplasia warranted resection rather than ablation as performed for the remaining Barretts esophagus. For these reasons, optical endomicroscopy performed on 5/30/18 was likely to have been superior over other available treatment options.
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A 42-year-old male enrollee has requested authorization and coverage for lumbar total disc arthroplasty (artificial disc). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. | Upheld | Experimental | Summary Reviewer 2
A 42-year-old male enrollee has requested authorization and coverage for lumbar total disc arthroplasty (artificial disc). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found the medical literature has not demonstrated the superior effectiveness of the requested services. The use of total disc arthroplasty has not been shown to be more beneficial than other more accepted surgical treatments such as fusion in the lumbar region. The long-term durability of these devices is unknown when subjected to the stresses of the lumbar spine. Therefore, the requested lumbar total disc arthroplasty (artificial disc) is not likely to be of greater benefit than other treatment options. For these reasons, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 55-year-old female enrollee has requested authorization and coverage for arthrodesis of sacroiliac (SI) joint (27279). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees SI joint pain.
SI joint pain confirmed by at least three positive SI joint provocative tests; confirmation of the SI joint as a pain generator
this case, the patient presents with chronic left SI joint pain.
activities of daily living and ambulatory ability. The records document up to three positive provocative SI joint tests on clinical examination. The provider reports a 75% reduction in pain with diagnostic injections, but the patient reports no benefit with any treatment attempted. Conservative treatment has included medications, activity modification, massage, acupuncture, and physical therapy. She has been diagnosed with a painful left SI joint condition but there is no imaging evidence consistent with SI joint spondyloarthropathy, | Upheld | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested authorization and coverage for arthrodesis of sacroiliac (SI) joint (27279). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees SI joint pain. The physician reviewer found that the International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive SI joint fusion provide specific indications for surgery. ISASS criteria includes: significant SI joint pain or significant limitations in activities of daily living because of SI joint pain; SI joint pain confirmed by at least three positive SI joint provocative tests; confirmation of the SI joint as a pain generator with at least 75% decrease in pain following fluoroscopically guided diagnostic intra-articular SI joint block in the immediate post-injection period; failure to respond to at least six months of non-surgical treatment including medications, rest, physical therapy, and SI joint steroid injection or rhizotomy; and, additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been clearly considered, investigated and ruled out. In this case, the patient presents with chronic left SI joint pain. Functional limitations are noted in activities of daily living and ambulatory ability. The records document up to three positive provocative SI joint tests on clinical examination. The provider reports a 75% reduction in pain with diagnostic injections, but the patient reports no benefit with any treatment attempted. Conservative treatment has included medications, activity modification, massage, acupuncture, and physical therapy. She has been diagnosed with a painful left SI joint condition but there is no imaging evidence consistent with SI joint spondyloarthropathy, degenerative sacroiliitis, or SI joint disruption. In addition, there is concern for lumbar spine and left hip pain generation. Therefore, the requested arthrodesis of SI joint (CPT code 27279) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 21-year-old female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that Arthroscopic resection is a very good option for medial plicae that do not respond to conservative treatment, and it must be initiated as a first option when cartilage damage is suspected. Prejbeanu and colleagues performed a large study of 267 patients who underwent symptomatic medial plica resection and had good results with long-term follow-up documented. There is sufficient support for the services at issue in this clinical setting. In sum, knee arthroscopy synovectomy performed on 12/20/17 was likely to have been more beneficial than other treatment options.
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patient is a 44-year-old female who presented to the emergency department on 10/13/19 with complaints of abdominal pain status post dirt bike accident. At the time of presentation, her vital signs were stable, with a heart rate of 112 and normal oxygen saturations on room air.
in this case, the patient was admitted in stable condition. Her pain was controlled with oral pain medications. She did not require any urgent surgery or procedures. Her vital signs were stable, and there was no evidence of hemodynamic instability or active bleeding. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 44-year-old female who presented to the emergency department on 10/13/19 with complaints of abdominal pain status post dirt bike accident. At the time of presentation, her vital signs were stable, with a heart rate of 112 and normal oxygen saturations on room air. The physician reviewer found that in this case, the patient was admitted in stable condition. Her pain was controlled with oral pain medications. She did not require any urgent surgery or procedures. Her vital signs were stable, and there was no evidence of hemodynamic instability or active bleeding. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting,
when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient admission provided from 10/13/19 through 10/14/19 was not medically necessary for the treatment of this patient. | 1 |
The patient is an 18-year-old male who presented for a psychiatric evaluation on 9/21/21. The
patient has requested reimbursement for RTC inpatient facility from 10/18/21 through 8/11/22.
The Health Insurer has denied this request and reported that the services at issue were not
medically necessary for the treatment of this patient.
to risk of harm, the records
support a score of 4. The patient had
risk of harm due to a history of suicidal ideation,
self-harm behaviors, and a past suicide attempt. At the time of admission to RTC, the patient
denied suicidal ideation but reported passive suicidal ideation two days prior to admission. The
patient continued to endorse suicidal ideation in December
he attributed to being in
residential treatment. In terms of functional status, the records
of 4. The
documentation noted serious functional impairment due to serious det | Overturned | Medical Necessity | Summary Reviewer
The patient is an 18-year-old male who presented for a psychiatric evaluation on 9/21/21. The
patient has requested reimbursement for RTC inpatient facility from 10/18/21 through 8/11/22.
The Health Insurer has denied this request and reported that the services at issue were not
medically necessary for the treatment of this patient. The physician reviewer found that The
American Academy of Child and Adolescent Psychiatry (AACAP) and American Association for
Community Psychiatry (AACP) have unified the Child and Adolescent Level of Care Utilization
System (CALOCUS) and the Child and Adolescent Service Intensity Instrument (CASII) into a single
instrument, the Child and Adolescent Level of Care/Service Intensity Utilization System
(CALOCUS-CASII). This instrument is a standardized tool used to determine the intensity of
services needed for children and adolescents, 6-18 years of age, presenting with psychiatric,
substance use, medical and/or developmental concerns. Using CALOCUS-CASII, providers score
patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions
include: (1) risk of harm; (2) functional status; (3) co-occurrence of developmental, medical,
substance use and psychiatric conditions; (4) recovery environment (a. stressors and b. supports);
(5) resiliency and response to services; and (6) engagement. The composite score is then used to
determine the level of care needed. Applying the CALOCUS-CASII framework, the patient met the
criteria for RTC services from 10/18/21 through 3/24/22. With regard to risk of harm, the records
support a score of 4. The patient had a serious risk of harm due to a history of suicidal ideation,
self-harm behaviors, and a past suicide attempt. At the time of admission to RTC, the patient
denied suicidal ideation but reported passive suicidal ideation two days prior to admission. The
patient continued to endorse suicidal ideation in December 2021 which he attributed to being in
residential treatment. In terms of functional status, the records support a score of 4. The
documentation noted serious functional impairment due to serious deterioration. Prior to
admission, the patient endorsed overwhelming anxiety and depression, was struggling in school,
and struggled in social interactions with peers. He presented as disheveled. With regard to
comorbidity, the records support a score of 3. The patient had significant comorbidity, due to the
presence of a neurodevelopmental disorder, ADHD. His developmental disability may adversely
affect the presenting condition and/or may require significant augmentation of alteration of
treatment for the presenting condition, or adversely affect the presenting condition. In terms of
the level of stress of the recovery environment, the records support a score of 3. The patient had
a moderately stressful environment. The records noted that the patient was bullied in middle
school but denied this as a source of trauma. The records noted that the patient reported
isolating and had difficulty interacting with peers. Role expectations appeared to exceed the
patients capacity given his age, status, and developmental level. With regard to the level of
support of the recovery environment, the records support a score of 3. The records suggest that
the patients parents were supportive, and he had supportive outpatient treatment providers.
However, community resources appeared to only partially compensate for the patients unmet
emotional needs and/or the patient had limited or inconsistent access to network. This is
consistent with limited support in the environment. In terms of resiliency and treatment history,
the records support a score of 5. The patient had negligible resiliency and/or response to
treatment as prior treatment included outpatient psychotherapy and psychiatric care including psychotropic medication, PHP, and several inpatient psychiatric hospitalizations. The patients
symptoms were persistent, and he showed no significant improvement in functional ability
despite intensive treatment exposure. The patients past response to treatment has been
minimal, even when treated at high levels of care for extended periods of time. With regard to
treatment acceptance and engagement, the records support a score of 3. While the patient
eventually engaged in treatment, as of February 2022 the patient was focused on returning
home, suggesting limited engagement. Thus, the patient had a total score of 25. The records
support a 4 in terms of functional status and risk of harm. In this case, the recommended level of
care was medically monitored residence-based services. With the functional impairment and
elevated risk of harm noted, the patient met CALOCUS 5b extended stay criteria from 10/18/21
through 3/24/22. Therefore, RTC inpatient facility from 10/18/21 through 3/24/22 was medically
necessary for the treatment of this patient. Applying the CALOCUS-CASII framework, this patient
did not meet the criteria for RTC services from 3/25/22 through 8/11/22. With regard to risk of
harm, the records support a score of 3. The patient had a significant risk of harm due to a history
of suicidal ideation, self-harm behaviors, and a past suicide attempt. At the time of admission to
RTC, the patient denied suicidal ideation but reported passive suicidal ideation two days prior to
admission. The patient continued to endorse suicidal ideation in December 2021 which he
attributed to being in residential treatment. However, individual therapy notes from 1/26/22
through August 2022 did not indicate suicidal ideation. In terms of functional status, the records
support a score of 3. The documentation noted moderate functional impairment due to serious
deterioration. Notes reported that the patients functioning in the milieu, school and community,
was above reproach. He was consistently observed as happy, helpful, energetic, and enthusiastic,
however, his affect and demeanor changed in the presence of clinical or administrative staff.
With regard to comorbidity, the records support a score of 3. The patient had significant
comorbidity, due to the presence of a neurodevelopmental disorder, ADHD. His developmental
disability may adversely affect the presenting condition and/or may require significant
augmentation of alteration of treatment for the presenting condition, or adversely affect the
presenting condition. In terms of the level of stress of the recovery environment, the records
support a score of 3. The patient had a moderately stressful environment. The records noted that
the patient was bullied in middle school but denied that this was a trauma. The records noted
that the patient reported isolating, and had difficulty interacting with peers. Role expectations
appear to exceed the patients capacity given age, status, and developmental level. With regard
to the level of support of the recovery environment, the records support a score of 3. The records
suggest that the patients parents are supportive, and he has supportive outpatient treatment
providers. However, community resources appear to only partially compensate for unmet
emotional needs and/or the adolescent had limited or inconsistent access to network. This is
consistent with limited support in the environment. In terms of resiliency and treatment history,
the records support a score of 5. The patient had negligible resiliency and/or response to
treatment as prior treatment has included outpatient psychotherapy and psychiatric care
including psychotropic medication, PHP, and several inpatient psychiatric hospitalizations. The
patients symptoms were persistent, and he showed no significant improvement in functional
ability despite intensive treatment exposure. The patients past response to treatment has been
minimal, even when treated at high levels of care for extended periods of time. With regard to
treatment acceptance and engagement, the records support a score of 2. As of 3/25/22, the patient appeared to be adequately engaged in treatment. Thus, the patient has a total score of
22. In this case, the recommended level of care was medically monitored community-based
services. This is consistent with the level of care that the patient received at the residential
treatment center. Therefore, RTC inpatient facility from 3/25/22 through 8/11/22 were not
medically necessary for the treatment of this patient.
| 1 |
A 64-year-old female enrollee has requested reimbursement for Botox injections received on 10/9/14 and 10/29/15. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old female enrollee has requested reimbursement for Botox injections received on 10/9/14 and 10/29/15. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found there is support in the medical literature for the services at issue in this clinical setting. Gabriel has demonstrated in a small but hypothesis-driven randomized clinical trial that botulinum effectively addresses the sources of severe pain associated with postmastectomy reconstruction. Although there were not any notable differences in the use of narcotic, muscle relaxants, or anti-inflammatory drugs observed for the two groups in the first three days after surgery, the botulinum group used significantly fewer doses of narcotics and muscle relaxants from days seven to 45 of recovery (Gabriel). Additionally, Gabriel found a statistically significant increase in the volume of expansion per office visit, leading to full expansion more quickly in the botulinum group than in the placebo group. Gabriels study is similar to the study by Layeeque and colleagues. In that trial, women injected with botulinum in the pectoral muscles in the time between mastectomy and tissue expander placement reported less postoperative pain and used fewer narcotics in the first 24 hours after surgery and in the final expansion period than patients who did not receive the agent. In sum, the use of Botox is an appropriate treatment for post-mastectomy breast reconstruction. For the reasons provided above, the Botox injections received on 10/9/14 and 10/29/15 were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 55-year-old male enrollee has requested reimbursement for the prostate cancer antigen 3 (PCA3) gene testing performed on 1/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 55-year-old male enrollee has requested reimbursement for the prostate cancer antigen 3 (PCA3) gene testing performed on 1/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the PCA3 testing was likely to be more effective for this patient than other available treatment options. PCA3 is expressed by most prostate cancers and has been analyzed as a screening test in clinical trials with sensitivities and specificities. PCA3 is appropriately used to recommend biopsy in those patients with indeterminate PSA levels or in those with initial negative prostate biopsies (Marks, et al; Deras, et al). In this case, the test was appropriately used to decide upon biopsy and the medical evidence supports it use in this clinical setting. In sum, the PCA3 testing was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 61-year-old male with a medical history including diabetes mellitus who presented to the emergency department after a bicycle versus car collision, resulting in multiple injuries. His injuries included a non-displaced clavicular fracture, left-sided rib fractures at ribs 4 and 6, a small pneumothorax and a pelvic fracture.
at the time of admission, the patient was hemodynamically stable without hypoxia. His pain was controlled. He did not suffer from any open traumatic fractures or head injury. There were no urgent procedures or surgeries | Upheld | Medical Necessity | Summary Reviewer
The patient is a 61-year-old male with a medical history including diabetes mellitus who presented to the emergency department after a bicycle versus car collision, resulting in multiple injuries. His injuries included a non-displaced clavicular fracture, left-sided rib fractures at ribs 4 and 6, a small pneumothorax and a pelvic fracture. The physician reviewer found that at the time of admission, the patient was hemodynamically stable without hypoxia. His pain was controlled. He did not suffer from any open traumatic fractures or head injury. There were no urgent procedures or surgeries required. The laboratory studies were mostly unremarkable, except for a mildly elevated glucose level. The inpatient admission was not medically necessary for this
patient. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition with improved symptoms and could have been treated at a lower level of care, like observation. He remained stable and did not have any complications that would require inpatient admission. Therefore, inpatient services provided from 10/12/20 through 10/13/20 were not medically necessary for the treatment of this patient.
| 1 |
patient is a 59-year-old male who presented with hematochezia in August 2021. The patient
has requested authorization and coverage for PET imaging with concurrent CT skull base to mid-
thigh. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 59-year-old male who presented with hematochezia in August 2021. The patient
has requested authorization and coverage for PET imaging with concurrent CT skull base to mid-
thigh. The physician reviewer found that there is sufficient support for the requested services in
this clinical setting. According to the National Comprehensive Cancer Network (NCCN) guidelines,
PET/CT has a limited sensitivity but high specificity, and may be considered when there is an
equivocal finding. When hepatocellular carcinoma is detected by CT or magnetic resonance
imaging (MRI) and has increased metabolic activity on PET/CT, higher intralesional standardized
uptake value (SUV) is a marker of biologic aggressiveness and might predict less optimal response
to locoregional therapies. Sensitivity is a metric for the screening of cancer, but for
discriminating responses, the specificity may be most relevant. The original disease showed
significant FDG uptake. There were multiple sites of disease making the interpretation of follow-
up imaging very complex. The use PET/CT is medically necessary for further care. Therefore, the
requested PET imaging with concurrent CT skull base to mid-thigh is medically necessary for the
evaluation of this patient.
| 1 |
A 39-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.
nonconcentric airway collapse, an AHI between 20 and 50, and a body mass index (BMI) less than 32. With a BMI of 31.1, AHI of 53.3 and nonconcentric airway collapse, this patient meets the criteria. He has failed CPAP, which | Overturned | Experimental | Summary Reviewer 1
A 39-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that obstructive sleep apnea is an increasingly prevalent clinical problem with significant effects on both personal and public health. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. Hypoglossal nerve stimulator has been found to be safe and effective in a small subset of patients with obstructive sleep apnea who have failed CPAP, have nonconcentric airway collapse, an AHI between 20 and 50, and a body mass index (BMI) less than 32. With a BMI of 31.1, AHI of 53.3 and nonconcentric airway collapse, this patient meets the criteria. He has failed CPAP, which is the gold standard treatment for obstructive sleep apnea. Therefore, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition.
the examination findings are non-focal. The laboratory examination was negative for Borrelia infection. | Upheld | Experimental | Summary Reviewer 2
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the medical evidence does not support the requested medication in this patients case. The patients symptoms are non-specific, and the examination findings are non-focal. The laboratory examination was negative for Borrelia infection. The diagnosis of late stage neuroborreliosis or Lyme arthritis has not been established. If the diagnosis of neuroborreliosis was established, the standard of care is one four-week course of intravenous ceftriaxone. Repeat or longer term courses of antibiotic have not been shown to be efficacious. The peer-reviewed literature does not demonstrate evidence for the requested medication in this clinical setting. All told, the requested intravenous ceftriaxone is not likely to be superior over other methods of treating this patient. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 36year-old female with a history of low back and right lower extremity pain due to a disc herniation at L4-5. The patient has requested reimbursement for anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
was 5.28 days. This patient has requested reimbursement for the surgery and two days of inpatient hospitalization. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 36year-old female with a history of low back and right lower extremity pain due to a disc herniation at L4-5. The patient has requested reimbursement for anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Phan and colleagues performed a meta-analysis of seven studies, including 181 patients who underwent anterior lumbar discectomy and fusion after primary discectomy had resulted in a recurrence of low back and leg pain, as in this patients case. The authors noted that there are certain advantages to the anterior approach. Repeat posterior approach for recurrent herniations may result in trauma to the spinal nerves and paraspinal muscles that is avoided in the anterior approach. Furthermore, the authors noted that the exposure allows for a comprehensive discectomy. In these 181 patients, there was significant improvement in the Oswestry Disability Index and Visual Analogue Scale (VAS) back and leg pain scores. The average length of hospital stay was 5.28 days. This patient has requested reimbursement for the surgery and two days of inpatient hospitalization. The authors concluded that anterior lumbar interbody fusion is a feasible approach for the treatment of recurrent lumbar disc herniations and demonstrates good results, with minimal complications. As such, in the presence of a recurrent herniation with chronic low back and leg pain, and failure of conservative treatment, the services at issue were medically indicated. Therefore, the anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization were medically necessary for the treatment of this patient.
| 1 |
A 45-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 1/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 45-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 1/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the molecular basis of neuroendocrine tumors remains poorly understood, and additional molecular predictors of outcome remain investigational. Per the National Comprehensive Cancer Network guidelines, more research is required before new molecular assays are routinely used in the clinic. A multinational consensus meeting of experts concluded that, to date, no single currently available biomarker is sufficient as a diagnostic, prognostic, or predictive marker in patients with neuroendocrine tumors. There are still treatment options available. Thus, FoundationOne CDx testing performed on 1/29/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 27-year-old female enrollee has requested reimbursement for inpatient level of care provided on 5/20/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The patient presented with symptoms consistent with urinary tract infection. At the time of admission, she was afebrile and hemodynamically stable. She did not have significant pain at the time of admission. She was tolerating oral hydration and could be treated with oral antibiotics. | Upheld | Medical Necessity | Summary Reviewer
A 27-year-old female enrollee has requested reimbursement for inpatient level of care provided on 5/20/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient presented with symptoms consistent with urinary tract infection. At the time of admission, she was afebrile and hemodynamically stable. She did not have significant pain at the time of admission. She was tolerating oral hydration and could be treated with oral antibiotics. There was no evidence of urinary tract obstruction. The inpatient admission was not medically necessary for this patient. She could have been treated at a lower level of care. Therefore, inpatient level of care provided on 5/20/19 was not medically necessary for the treatment of this patient. | 1 |
A 54-year-old female enrollee has requested reimbursement for left and right eye refraction surgery performed on 9/19/16 and 10/07/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has a history of blurred vision.
The records show that the patient did have symptomatic cataracts requiring surgery. | Overturned | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested reimbursement for left and right eye refraction surgery performed on 9/19/16 and 10/07/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has a history of blurred vision. The physician reviewer found that the submitted submitted documentation supports the medical necessity of a portion of the services at issue. The records show that the patient did have symptomatic cataracts requiring surgery. The Health Insurers argument that the surgery was purely for refractive reasons was not substantiated upon reviewing the medical records. Thus, the portion of surgeries to treat cataract was medically necessary. The additional treatments of femtosecond laser and multifocal intraocular lens were for the purpose of refractive treatment and were not medically necessary. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned. | 1 |
A 61-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees lung cancer. | Overturned | Experimental | Summary Reviewer 1
A 61-year-old female enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees lung cancer. The physician reviewer found that of the original indications for PET scan was the evaluation of solitary pulmonary nodules to determine the likelihood of malignancy based on high standardized uptake values (SUV). Primary lung cancer greater than 1 cm in diameter has a very high true positive rate on PET/CT versus other post therapy and infectious etiologies. In this patient with a question of recurrent lung cancer versus scar formation and the contraindication of biopsy of the lesion due to severe COPD, PET scan is likely to be more beneficial than other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 32-year-old female who presented to her provider on 8/31/21. The records noted
that the patient was 66.5 inches tall and weighed 296.6 pounds, with a body mass index (BMI) of
47.15 kg/m2. The patient has requested authorization and coverage for (1) Mounjaro 7.5 mg, (2)
Ozempic 2 mg, and (3) Rybelsus 7 mg. The Health Insurer has denied this request and reported
that the requested medications are not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary
The patient is a 32-year-old female who presented to her provider on 8/31/21. The records noted
that the patient was 66.5 inches tall and weighed 296.6 pounds, with a body mass index (BMI) of
47.15 kg/m2. The patient has requested authorization and coverage for (1) Mounjaro 7.5 mg, (2)
Ozempic 2 mg, and (3) Rybelsus 7 mg. The Health Insurer has denied this request and reported
that the requested medications are not medically necessary for the treatment of this patient. This
denial is the subject of this appeal and determination. The physician reviewer found that the
submitted documentation does not support the medical necessity of the requested medications.
Prediabetes is defined as an elevated hemoglobin A1C in the range of 5.7% to 6.4%. Some
individuals with prediabetes may progress to developing diabetes mellitus. The American Diabetes
Association (ADA) guidelines on the prevention of type 2 diabetes recommend that individuals
with prediabetes undergo counseling on lifestyle changes including weight loss and routine
exercise. The ADA recommends that the only pharmacologic agent to be considered for use for
prediabetes is metformin for those at high risk for developing diabetes. Obesity is a disease
associated with many health risks, including type 2 diabetes mellitus, hypertension, dyslipidemia,
and coronary heart disease. Weight loss in patients with obesity or who are overweight is
associated with a reduction in mortality. The American Association of Clinical Endocrinologists
guidelines for the medical care of patients with obesity notes that patients with obesity or who are
overweight and with dyslipidemia should be considered for treatment with a weight-loss
medication combined with lifestyle therapy when necessary to achieve sufficient improvements in
lipids. The guidelines further note that for patients who struggle with weight loss and who would
receive health benefit from weight loss, management of medications that are contributing to weight
gain and the use of approved medications for chronic weight management along with lifestyle
changes are appropriate. Medications for weight loss are generally considered an option for
patients with a BMI over 27 kg/m2 with comorbidities such as diabetes or sleep apnea, or a BMI
over 30 kg/m2 without comorbidities. There are multiple medications approved by the U.S. Food
and Drug Administration (FDA) for the treatment of obesity including orlistat, naltrexone-
bupropion, lorcaserin, phentermine, phentermine with topiramate, liraglutide and semaglutide.
WIlding and colleagues note that semaglutide has demonstrated impressive efficacy in weight
reduction, along with improvement in blood sugars and cholesterol levels. Semaglutide is available
under the brand name Wegovy, Ozempic and Rybelsus. The FDA approves the use of Wegovy to
assist patients with obesity, or who are overweight with weight-related medical problems, to lose
weight when added to diet and exercise. The FDA approves the use of Ozempic and Rybelsus to
lower blood sugar levels in adults with type 2 diabetes, in addition to diet and exercise. The FDA
approves the use of tirzepatide (Mounjaro), a unique dual glucagon-like peptide-1 (GLP-
1)/glucagon receptor (GIP) agonist, for the treatment of type 2 diabetes. In an open-label, parallel-
group, randomized, active-controlled trial examining the benefits on weight loss of tirzepatide
versuss semaglutide in over 1,800 patients with type 2 diabetes over 40 weeks, Frias and colleagues
concluded that reductions in body weight were greater with tirzepatide than with semaglutide.
While concurrent medications for weight loss may be appropriate for patients with a BMI over 27
kg/m2 with comorbidities, in this case, the patients most recent BMI is 25.8 kg/m2 and the patient
reports that her comorbidities of hypertension and hyperlipidemia have resolved. While published
studies support the use of Mounjaro, Ozempic, and Rybelsus as effective for weight loss, given
the lack of data available on their benefits over FDA approved medications for weight loss in
patients without diabetes or obesity, the requested medications are not medically indicated. Therefore, (1) Mounjaro 7.5 mg, (2) Ozempic 2 mg, and (3) Rybelsus 7 mg are not medically
necessary for the treatment of this patient.
| 1 |
The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the clinical practice guidelines adopted by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition support the use of proton pump inhibitors in infants with severe gastroesophageal reflux disease if a trial of hydrolyzed formula has failed. The use of proton pump inhibitors in infants with severe gastroesophageal reflux disease is consistent with the standard of care. The safety and efficacy of this class of medications are well-established and supported by sufficient scientific evidence. This patient has already failed to respond to hydrolyzed formula and to acid suppression with H2 blockers. A trial of a proton pump inhibitor is the most appropriate next step in the management of this patient. Therefore, lansoprazole is likely to be more efficacious than other treatment options.
| 1 |
A 52-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 52-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines states that while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. In sum, DecisionDx-Melanoma gene expression testing performed on 11/01/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 50-year-old male enrollee has requested reimbursement for BCR/ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
this patient has a grade I meningioma. Magnetic resonance imaging (MRI) showed a question of slow growth versus | Upheld | Experimental | Summary Reviewer 1
A 50-year-old male enrollee has requested reimbursement for BCR/ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient has a grade I meningioma. Magnetic resonance imaging (MRI) showed a question of slow growth versus tumor progression. There is no rationale for molecular profiling or BCR-ABL testing in this patient. Molecular profiling is used to determine treatment options in certain malignancies, but not grade I meningiomas. BCR-ABL is used in the detection and monitoring of chronic myelogenous leukemia, acute myeloid leukemia and acute lymphoblastic leukemia. In rare cases, BCR-ABL1 has been described in essential thrombocytosis, myelodysplastic syndrome, multiple myeloma (plasma cell myeloma), and malignant lymphoma. Therefore, BCR-ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18 were not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 51-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/15/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 1
A 51-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/15/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found by monitoring patients on infliximab with measurement of infliximab levels and antibodies to infliximab continues to be an area of intense investigation. In general, infliximab levels correlate inversely with disease activity. However, the target level of infliximab necessary to achieve clinical benefit remains unknown. There is a lack of support for the services at issue in this clinical setting. Many patients lose response to a tumor necrosis factor (TNF) alpha inhibitor for unclear reasons. All told, Anser IFX testing performed on 4/15/14 was not likely to have been of greater benefit than other methods of evaluation. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 65-year-old female enrollee has requested reimbursement for inpatient admission from 12/06/17 through 12/07/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
the patient presented with anginal type symptoms after a stressor. Although she did not have fixed coronary artery disease, she
and an echocardiogram, which revealed severe apical hypokinesis with depressed ejection fraction. | Overturned | Medical Necessity | Summary Reviewer
A 65-year-old female enrollee has requested reimbursement for inpatient admission from 12/06/17 through 12/07/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the patient presented with anginal type symptoms after a stressor. Although she did not have fixed coronary artery disease, she met all the criteria for Takasubos stress cardiomyopathy with T wave inversions, positive low-level troponin elevations and an echocardiogram, which revealed severe apical hypokinesis with depressed ejection fraction. Although not often associated with fixed coronary artery disease, the prognosis for stress cardiomyopathy is also very guarded, and recent data and meta-analyses reveal that there is significant short and long-term morbidity and mortality associated with this entity. Therefore, monitoring for rhythm disturbances, hypotension and other complications of myocardial infarction is warranted with an inpatient admission, even if short. Troponins, electrocardiogram and echocardiogram all showed evidence of acute myocardial damage in this patient. Therefore, inpatient admission from 12/06/17 through 12/07/17 was medically necessary for the treatment of this patient. | 1 |
A 62-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 7/25/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 7/25/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that the therapy of advanced non-small cell lung cancer (NSCLC) has been revolutionized by the finding of EGFR mutations in adenocarcinomas. Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimen. The mutational landscape of NSCLC has significantly expanded to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. Thus, mutational analysis on its own is clinically indicated in these cases of NSCLC. Plasma cell free/circulating tumor DNA testing is indicated if the primary tumor is inaccessible. According to the National Comprehensive Cancer Network guidelines, In the initial diagnostic setting, if following pathologic confirmation of NSCLC diagnosis there is insufficient material for molecular analysis, cell free/circulating tumor DNA should be used only if follow-up tissue based analysis is planned for all patients in which an oncogenic driver is not identified. In this case, insufficient material was available after the biopsy. The medical evidence supports the services at issue in this patients case. Therefore, Guardant360 testing performed on 7/25/20 was likely to have been more beneficial than any available standard therapy.
| 0 |
The patient is a 62-year-old male with a progressive group of symptoms consistent with a neurodegenerative disorder. He has developed dysarthria, ataxia and possibly cognitive abnormalities of executive functioning. Per the records, magnetic resonance imaging (MRI) of the brain showed atrophy of the cerebellum, cerebellar peduncles, and pons and medulla consistent with multisystem atrophy or possibly spinocerebellar degeneration. The provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. | Upheld | Experimental | Summary Reviewer 1
The patient is a 62-year-old male with a progressive group of symptoms consistent with a neurodegenerative disorder. He has developed dysarthria, ataxia and possibly cognitive abnormalities of executive functioning. Per the records, magnetic resonance imaging (MRI) of the brain showed atrophy of the cerebellum, cerebellar peduncles, and pons and medulla consistent with multisystem atrophy or possibly spinocerebellar degeneration. The provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. There is a lack of support for the services at issue in this clinical setting. The differential diagnosis of spinocerebellar degeneration versus multiple system atrophy is established by clinical grounds. There is a lack of data demonstrating adequate sensitivity or specificity of DaT SPECT scanning in this clinical setting. Therefore, DaT SPECT scan of the brain performed on 9/23/16 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
An 18-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 52 hours per month of applied behavioral analysis (ABA) therapy provided from 10/1/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder. | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 52 hours per month of applied behavioral analysis (ABA) therapy provided from 10/1/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.The physician reviewer found that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the services at issue. ABA is the standard of care for treating children with autism and the medical literature supports the treatment of autistic children with ABA therapy. Although ABA therapy is the mainstay of successful treatment of autism, its successful prolonged improvement of behavior is limited to approximately 50 percent of the patient population (Vismara and Rogers). Moreover, there is a lack of medical literature showing the effectiveness of ABA therapy applied to autistic adults. In this case, the patient has adequate language, but also has difficulty in establishing social contacts and interactions. Social skills group has been suggested to improve social competence in patients aged 6 to 21 (Reichow, et al). Therefore, based upon the medical literature cited above and the documentation submitted for review, the services at issue were not and are not medically necessary. The Health Insurers denial should be upheld.
| 0 |
A 50-year-old male enrollee has requested reimbursement for BCR/ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 50-year-old male enrollee has requested reimbursement for BCR/ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that testing for BCR-ABL is a gene mutation particularly prominent in chronic myelogenous leukemia, for which there is a specific targeted treatment (imatinib). There has been interest in using this drug in meningioma, although the results have been equivocal at best. There is a lack of convincing data that imatinib, regardless of mutational status, is clinically beneficial in meningioma. The Tempus XT gene panel is one of many multigene panels theoretically designed to identify a gene target for therapy. Thus far, the use of such panels appears to be rarely beneficial overall. In sum, BCR-ABL gene rearrangement and the Tempus XT Gene Panel Testing performed on 12/17/18 were not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 58-year-old female enrollee has requested reimbursement and prospective authorization for Forteo 20 mcg from 1/15/16 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old female enrollee has requested reimbursement and prospective authorization for Forteo 20 mcg from 1/15/16 forward. The Health Insurer has denied this request indicating that the medication at issue was not and is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the medication at issue in this clinical setting. Osteoporosis is an increasingly widespread condition, and fractures are the most dangerous aspect of osteoporosis. They can lead to acute and chronic pain as well as increased mortality. Until recently, pharmacological options for the treatment of osteoporosis have been limited to anti-resorptive agents, including bisphosphonates. Newer treatment agents have become available over the past few years, including teriparatide (Forteo). Forteo is a recombinant form of the biologically active component of parathyroid hormone which has been shown to increase bone mass and prevent fractures in osteoporotic bone. In contrast to anti-resorptive agents, such as bisphosphonates and Prolia, recent data also demonstrates that Forteo may aid in the healing of fractures and non-unions in osteoporotic patients. Therefore, Forteo 20 mcg from 1/15/16 forward was and is medically indicated for the treatment of this patient. Therefore, the medication at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 62-year-old male enrollee has requested reimbursement for hyaluronan injections in the knee performed on 12/13/17, 12/18/17, 12/27/17, 1/05/18 and 1/12/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees osteoarthritis.
This patient presented on 12/01/17 for follow-up regarding his left knee. It was noted that there was MRI evidence of tricompartmental osteoarthritis, most severe in the patellofemoral joint and a mild joint effusion. | Upheld | Medical Necessity | Summary Reviewer
A 62-year-old male enrollee has requested reimbursement for hyaluronan injections in the knee performed on 12/13/17, 12/18/17, 12/27/17, 1/05/18 and 1/12/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees osteoarthritis. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient presented on 12/01/17 for follow-up regarding his left knee. It was noted that there was MRI evidence of tricompartmental osteoarthritis, most severe in the patellofemoral joint and a mild joint effusion. A left knee examination is not documented in the submitted medical records, and functional limitations are not discussed. Detailed evidence of a recent, reasonable and/or comprehensive nonoperative treatment protocol trial, including nonsteroidal anti-inflammatory drugs, exercise, and corticosteroid injections, and failure has not been submitted. There is evidence-based medical literature support for the use of hyaluronan acid (Supartz) injections in the treatment of significantly symptomatic osteoarthritis of the knee, when conservative treatment has failed. However, in this case, there is no clinical evidence documented to support a diagnosis of severe osteoarthritis or functional limitations discussed. Therefore, hyaluronan injections in the knee performed on 12/13/17, 12/18/17, 12/27/17, 1/05/18 and 1/12/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 30-year-old male enrollee has requested reimbursement for L0637 (lumbar support brace) provided on 1/7/15. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees low back pain.
On 1/7/16, the office visit indicates that the patient reports to improving 10% since the onset. | Upheld | Medical Necessity | Summary Reviewer
A 30-year-old male enrollee has requested reimbursement for L0637 (lumbar support brace) provided on 1/7/15. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees low back pain. The physician reviewer found that based on the clinical records submitted for review, the L0637 (lumbar support brace) provided on 1/7/15 was not medically necessary for treatment of the patients medical condition. The office visit dated 1/7/15 does not provide sufficient rationale supporting the clinical indication for the lumbar support brace provided. On 1/7/16, the office visit indicates that the patient reports to improving 10% since the onset. Given that the patient had improved and in the absence of clinical rationale supporting the device, the L0637 (lumbar support brace) provided on 1/7/15 was not medically necessary for treatment of the patients medical condition. Therefore, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician
that the patient has paroxysmal atrial fibrillation. He requires anticoagulation therapy for life and has been maintained on Eliquis therapy. He has a high-risk occupation for trauma and is on job sites daily by report. | Overturned | Experimental | Summary Reviewer 1
A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the patient has paroxysmal atrial fibrillation. He requires anticoagulation therapy for life and has been maintained on Eliquis therapy. He has a high-risk occupation for trauma and is on job sites daily by report. The Watchman atrial appendage occluder device has been approved by the U.S. Food and Drug Administration (FDA) for this indication and is recommended for consideration in patients with either an absolute or relative contraindication to long-term anticoagulation. It is not considered an investigational device in these clinical situations. This patient has a relative contraindication to anticoagulation and is a good candidate for Watchman. Therefore, percutaneous transcatheter closure of the left atrial appendage with endocardial implant is likely to be more beneficial than other available standard therapy.
| 1 |
A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested reimbursement for St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the services at issue were not likely to be more effective for this patient than other available options. Leadless pacemakers are currently considered controversial and there is a lack of documented contraindications to placement of a traditional endocardial lead. Studies in the peer-reviewed literature suggest that long term complications remain to be determined (Reddy, et al; Miller, et al). All told, the St. Jude Nanostim Leadless Pacemaker implant provided on 6/24/15 has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
X Prostate testing was performed after this patientas 2019 biopsy. Despite being placed into the | Upheld | Experimental | Summary Reviewer 3
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that there currently are three major approaches to the management of localized prostate cancer. These include surgery, forms of radiation therapy, or active surveillance, with no specific anti-cancer treatment given. Treatment recommendations are made as to these options based on risk stratification, which will estimate the risk of the future development of progressive cancer. The individualas situation is evaluated, incorporating clinical factors, as well as PSA and the details of the prostate biopsy. By such methodology, the patient is placed into a risk category, ranging from very low risk, to low risk, to intermediate risk, to high risk.
A further refinement of prognostication is the use of genomic panels, such as Oncotype. This is a 17-gene panel which seems capable of predicting recurrence after treatment for prostate cancer. NCCN guidelines suggest it may be useful in decision making in the low to intermediate risk category in the initial assessment of the cancer and its treatment. In this case, Oncotype DX Prostate testing was performed after this patientas 2019 biopsy. Despite being placed into the intermediate risk category, he elected active surveillance only. Although there was minimal to no change in his clinical status in his repeat biopsy, he was considering specific treatment. In this setting, repeat Oncotype DX Prostate testing was not likely to have added to the clinical decision making, as he already had a concerning Oncotype assay in 2019. NCCN guidelines do not support the services at issue in this setting. Therefore, Oncotype DX Prostate testing performed on 7/23/20 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. The Health Insurer has
denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
This patient reported persistent odor for one month. No discharge
was noted on examination, and nitrazine was noted to negative. | Overturned | Experimental | Summary Reviewer 1
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. The Health Insurer has
denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
The physician reviewer found that there is sufficient support for the
services at issue in this clinical setting. Patients with vaginitis can
be evaluated and treated with an examination, microscopy and/or cultures
depending on the patients symptoms and findings. The exact process
depends on the provider and the resources available at that particular
office. This patient reported persistent odor for one month. No discharge
was noted on examination, and nitrazine was noted to negative.
be
Evaluation with PCR testing was consistent with standard of care in this
setting. Therefore, PCR testing performed on 4/29/19 was likely to have
been more beneficial than any available standard therapy.
| 1 |
A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
The patient presented with an acute undiagnosed infection with negative stool studies. | Overturned | Experimental | Summary Reviewer 1
A 54-year-old male enrollee has requested reimbursement for the Prometheus diagnostic panel performed on 11/24/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Prometheus diagnostic panel performed on 11/24/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The patient presented with an acute undiagnosed infection with negative stool studies. To acquire objective data to provide effective treatment management for this patient the use of the diagnostic panel was indicated. The Prometheus diagnostic panel combines serologic, genetic, and inflammatory markers to help differentiate IBD from non-IBD. The testing at issue was indicated to evaluate whether his symptoms were predictive of IBD or another cause of colitis. Therefore, the testing at issue has been established as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
The patient has been exposed to other biologics in the same class. | Upheld | Experimental | Summary Reviewer 1
A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence does not support the services at issue in this clinical setting. The records do not demonstrate the clinical rationale for this testing. The patient has been exposed to other biologics in the same class. Anser IFX testing is not standard of care in this clinical setting. All told, Anser IFX testing performed on 4/02/15 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old male enrollee has requested reimbursement for residential treatment center services provided from 5/30/16 through 6/30/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
. He presented for admission with ambivalence, and while in treatment developed a responsible drinking plan. | Upheld | Medical Necessity | Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for residential treatment center services provided from 5/30/16 through 6/30/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer that the residential treatment center services provided from 5/30/16 through 6/30/16 were not medically necessary for treatment of the patients medical condition. On admission the patient was not in withdrawals. There was no evidence of post-acute withdrawal symptoms. He was not a danger to self or others. Both his medical and psychiatric conditions could have been treated on an outpatient basis. He was not psychotic or manic. There were no emotional, behavioral, cognitive, or impulsive symptoms to justify residential level of care. He presented for admission with ambivalence, and while in treatment developed a responsible drinking plan. The goal of treatment is abstinence with ongoing vigilance to prevent relapse. In this case, the patient could have been treated at a lower level of care such as intensive outpatient program (IOP) or outpatient with a concurrent 12-step program, and continuation with his psychotherapist. As such, the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 0 |
A 56-year-old female enrollee has requested reimbursement for the Foundation One genetic testing provided on 1/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent ovarian cancer. | Upheld | Experimental | Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for the Foundation One genetic testing provided on 1/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent ovarian cancer. The physician reviewer found that molecular profiling is an assay of an individual patients cancer cells to detect specific genomic or molecular abnormalities that might serve as a target for a potential treatment. There are multiple non-randomized clinical trials exploring the value of molecular profiling. However, there is a lack of data from these trials demonstrating improved health outcomes based on the findings in these assays (Von Hoff, et al). Currently, there is a paucity of scientific data suggesting that the Foundation One genetic testing performed on 1/12/15 was likely to have been more beneficial for evaluation of this patients medical condition than standard available testing. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld. | 1 |
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, the superior effectiveness of DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen has not been established in this patients case. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 63-year-old male who presents with recurrent sinusitis with symptoms of rhinorrhea, nasal congestion, nasal discharge and facial pain. The patients prior medical history is also significant for moderate persistent asthma, allergic rhinitis, gastroesophageal reflux disease (GERD), hypertension, and deviated septum/polyps. The patient also with reported history of asthma with complaints of cough and wheezing. The patients has been treated with ProAir HFA, Flonase, fluoxetine, intranasal saline, and Losartan. The patient has requested authorization and coverage for Dulera 100 mcg/5 mcg inhaler. The Health Insurer has denied this request indicating that the requested medication is not medically necessary. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 63-year-old male who presents with recurrent sinusitis with symptoms of rhinorrhea, nasal congestion, nasal discharge and facial pain. The patients prior medical history is also significant for moderate persistent asthma, allergic rhinitis, gastroesophageal reflux disease (GERD), hypertension, and deviated septum/polyps. The patient also with reported history of asthma with complaints of cough and wheezing. The patients has been treated with ProAir HFA, Flonase, fluoxetine, intranasal saline, and Losartan. The patient has requested authorization and coverage for Dulera 100 mcg/5 mcg inhaler. The Health Insurer has denied this request indicating that the requested medication is not medically necessary. There was no documentation provided in terms of spirometry, bronchodilator response or bronchoprovocation testing that this patient has a confirmed diagnosis of asthma. In addition, no records were provided on the patients current symptoms or longevity of disease. Furthermore, there is no documentation that the patient has failed treatment with other inhaled corticosteroid/long-acting B2-agonist (ICS/LABA) medications such as Advair, Breo, Symbicort, or generic fluticasone/salmeterol, which are on the Health Insurers formulary. Given these findings, the requested Dulera 100 mcg/5 mcg inhaler is not supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of an 11-year-old male enrollee has requested reimbursement for the FirstStepDx PLUS test provided on 7/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees attention deficit hyperactivity disorder (ADHD). | Overturned | Experimental | Summary Reviewer 3
The parent of an 11-year-old male enrollee has requested reimbursement for the FirstStepDx PLUS test provided on 7/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees attention deficit hyperactivity disorder (ADHD). The physician reviewer found that array-based comparative genomic hybridization, also known as chromosomal microarray (CMA) has become standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. The yield of this test is 8-17% and varies with the degree of cognitive impairment, the presence of dysmorphic features, and the presence of congenital anomalies. The patients presentation meets the criteria established for microarray use with autism spectrum disorder and a congenital anomaly. In addition, the patients positive family history provides additional support for testing (Baris, et al; Johnson, et al). Henderson and colleagues demonstrated that approximately 12.7% of patients meeting referral criteria had a pathogenic copy number variant identified on microarray, and that half of those results influenced management. Riggs and colleagues found that 7% of microarray results impact clinical management, a rate which is similar to other genetic tests. Data have now emerged showing that actionable findings from chromosomal microarray justify its use. Thus, the FirstStepDx PLUS test provided on 7/6/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 3
A 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that in this patients case, Anser IFX testing was ordered to determine Remicade (infliximab) level and whether antibodies to infliximab were present. The use of Anser IFX to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have clear infliximab levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing. Based on the clinical literature, Anser IFX testing performed on 2/25/16 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection. | Overturned | Experimental | Summary Reviewer 2
The parent of a 12-year-old male enrollee has requested authorization and coverage for real-time intra-fraction target tracking for planned proton beam radiotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees craniopharyngioma status post resection. The physician reviewer found that Overall penumbra volume should be reduced by 50-70% as a result of tracking and therefore may provide reduction in hypothalamic and brain doses. In light of the patients cerebrovascular accident, any further damage to normal central nervous system tissues is likely to be detrimental. The 2 mm or better fixation offered by a thermoplastic mask is adequate to support that the real-time intra-fractional target tracking is likely to be more beneficial than standard alternatives since the tumor is already in contact with the optic pathway. Based upon the information set forth above, I have determined the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease.
A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied | Upheld | Experimental | Summary Reviewer 1
A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that in this case, Anser ADA was used to direct the management of the patients Crohns disease. However, the use of the Anser ADA test has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with Humira may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). Moreover, prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Therefore, clinical literature does not support the Anser ADA test performed on 1/11/16 as likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the Prometheus Anser ADA test is a quantitative measurement of serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of adalimumab or the presence of ADA antibodies have an adverse effect on the clinical outcome of a patients response to treatment. While there have been testimonials, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). As such, the clinical utility of measuring drug antibody concentrations has not been established, and it has not been determined how patient management should change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement (Yanai, et al). All told, the Anser ADA testing performed on 1/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma test for melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient. | 0 |
A 50-year-old female has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 50-year-old female has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this clinical setting. Polly and colleagues performed a randomized controlled trial comparing minimally invasive sacroiliac joint fusion using triangular titanium implants to nonsurgical treatment at 12 months. A total of 148 patients with sacroiliac joint dysfunction were randomly assigned to minimally invasive sacroiliac joint fusion with triangular titanium implants or nonsurgical treatment. The conclusion was that this level one study showed that minimally invasive sacroiliac joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with sacroiliac joint dysfunction caused by degenerative sacroiliitis or sacroiliac joint disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. Based upon a review of the literature, the requested sacroiliac joint fusion is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 23-year-old female enrollee has requested reimbursement for the substance use residential rehabilitation services provided from 10/10/16 through 1/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees substance abuse. The physician
that the records provided for review document that this patient showed mild post-acute withdrawal symptoms and there was no evidence of suicidal or homicidal ideation. She attended to her activities of daily living and was cognitively intact. Emotionally she related that she wanted to grieve before participating in treatment. She did not demonstrate impulsivity. She did not show motivation or cooperation. Medically she was stable as her rheumatoid arthritis and medication therapy could have been managed on an ambulatory basis. She was at risk for relapse, however she was highly resistant. It was not until 10/15/16 that she began to show cooperation and motivation. | Upheld | Medical Necessity | Summary Reviewer
A 23-year-old female enrollee has requested reimbursement for the substance use residential rehabilitation services provided from 10/10/16 through 1/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees substance abuse. The physician reviewer found that the records provided for review document that this patient showed mild post-acute withdrawal symptoms and there was no evidence of suicidal or homicidal ideation. She attended to her activities of daily living and was cognitively intact. Emotionally she related that she wanted to grieve before participating in treatment. She did not demonstrate impulsivity. She did not show motivation or cooperation. Medically she was stable as her rheumatoid arthritis and medication therapy could have been managed on an ambulatory basis. She was at risk for relapse, however she was highly resistant. It was not until 10/15/16 that she began to show cooperation and motivation. Overall, the patient did not require 24-hour per day supervised medical and nursing level of care in residential treatment. She could have been treated in a less restrictive treatment setting in conjunction with community supports with 12 step programs, and a Subutex maintenance program on an outpatient basis. Thus, the substance use residential rehabilitation services provided from 10/10/16 through 1/6/17 was not medically necessary for treatment of this patients medical condition. Based on these findings, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 26-year-old female enrollee has requested reimbursement for CPT code 81291 performed on 10/11/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a family history of a clotting disorder. | Upheld | Experimental | Summary Reviewer 2
A 26-year-old female enrollee has requested reimbursement for CPT code 81291 performed on 10/11/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a family history of a clotting disorder. The physician reviewer found there is is support for the services at issue in this clinical setting. As it relates specifically to evaluation of pregnancy losses, the testing performed is not indicated. However, the medical evidence supports testing when a patient or a first-degree relative has a history of a thrombotic event. This patients family history indicates that she may be at higher risk during pregnancy and during the immediate postpartum time period, and the results of this testing may impact patient management. Therefore, CPT code 81291 performed on 10/11/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 59-year-old male enrollee has requested reimbursement for Guardant 360 testing performed
on 3/31/21. The Health Insurer has denied this request and reported that the services at issue
were investigational for the evaluation of the enrollees medical condition.
This patient did not have enough tissue for molecular
testing for driver mutations, and | Overturned | Experimental | Summary Reviewer 1
A 59-year-old male enrollee has requested reimbursement for Guardant 360 testing performed
on 3/31/21. The Health Insurer has denied this request and reported that the services at issue
were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that cell-free/circulating tumor DNA testing should not be used in lieu of a
histologic tissue diagnosis. Some laboratories offer testing for molecular alterations examining
nucleic acids in peripheral circulation, most commonly in processed plasma (sometimes referred
to as liquid biopsy). Studies have demonstrated cell-free tumor DNA testing to generally have
very high specificity, but significantly compromised sensitivity, with up to 30% false-negative
rate. Standards for analytical performance characteristics of cell-free tumor DNA have not been
established, and in contrast to tissue-based testing, no guidelines exist regarding the
recommended performance characteristics of this type of testing. Cell-free tumor DNA testing
can identify alterations that are unrelated to a lesion of interest, for example, clonal
hematopoiesis of indeterminate potential. This patient did not have enough tissue for molecular
testing for driver mutations, and liquid biopsy was performed. The medical evidence supports
the services at issue in this setting. Therefore, Guardant 360 testing performed on 3/31/21 was
likely to have been more beneficial than any available standard therapy.
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The patient is a 55-year-old female with a history of rheumatoid arthritis manifested by synovitis of the small and large joints and fatigue. On 8/18/16, the records noted that she had been treated with Remicade, methotrexate and Xeljanz. The documentation indicated that the patient had responded to Remicade in the past, but this was discontinued due to cost. The provider reported reluctance to resume Remicade due to concern for infusion reaction. The provider ordered Prometheus Anser IFX testing. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. | Upheld | Experimental | Summary Reviewer 2
The patient is a 55-year-old female with a history of rheumatoid arthritis manifested by synovitis of the small and large joints and fatigue. On 8/18/16, the records noted that she had been treated with Remicade, methotrexate and Xeljanz. The documentation indicated that the patient had responded to Remicade in the past, but this was discontinued due to cost. The provider reported reluctance to resume Remicade due to concern for infusion reaction. The provider ordered Prometheus Anser IFX testing. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. The current medical evidence does not support the services at issue in this patients case. Prometheus Anser IFX testing can measure antibodies to Remicade (infliximab). However, there is a lack of peer-reviewed, evidence-based medical literature to support the use of Prometheus Anser IFX testing in the management of rheumatoid arthritis. Additionally, the available medical records do not adequately document the providers rationale for the request of this test. All told, the superior effectiveness of Prometheus Anser IFX testing performed on 8/19/16 has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 51-year-old male enrollee has requested reimbursement for home healthcare services which include intravenous infusion of ceftriaxone, Benadryl, associated supplies and office visits with Miguel Gonzalez, MD from dates of service 9/11/15 through 12/09/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
. In spite of this, the provider ordered intravenous ceftriaxone. This drug | Upheld | Medical Necessity | Summary Reviewer
A 51-year-old male enrollee has requested reimbursement for home healthcare services which include intravenous infusion of ceftriaxone, Benadryl, associated supplies and office visits with Miguel Gonzalez, MD from dates of service 9/11/15 through 12/09/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient has a long history of a variety of non-specific complaints. The clinical evidence and the laboratory studies provided for review do not support a diagnosis of any tick borne diseases or Lyme disease. The Borrelia burgdorferi serologies completed in March 2015 are negative. In spite of this, the provider ordered intravenous ceftriaxone. This drug is recommended for Lyme disease associated arthritis, carditis or neurological disease. The records do not document that this patient had the rash typical of early Lyme disease, and his reported symptoms are not suggestive of this diagnosis. In sum, home healthcare services which include intravenous infusion of ceftriaxone, Benadryl, associated supplies and office visits with Miguel Gonzalez, MD from dates of service 9/11/15 through 12/09/15 were not medically indicated for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases.
The records document a prostate-specific antigen (PSA) level of 0.96 ng/mL and a palpable nodule. The patient had a negative biopsy for prostate cancer. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The records document a prostate-specific antigen (PSA) level of 0.96 ng/mL and a palpable nodule. The patient had a negative biopsy for prostate cancer. Per the medical evidence, 4Kscore is indicated for patients with PSA levels greater than 3 ng/mL without a palpable lesion. The medical evidence does not support the services at issue in this patients case, as the records noted a palpable lesion and a PSA level which was below 3 ng/mL. Therefore, the blood test (protein biomarker tests or 4Kscore) performed on 10/29/18 was not likely to have been more efficacious than other methods of evaluating this patient.
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The parent of a 14-year-old male enrollee has requested reimbursement for residential mental health treatment services provided from 4/25/16 through 12/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD). | Upheld | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement for residential mental health treatment services provided from 4/25/16 through 12/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD). The physician reviewer found that the records provided for review do not support the medical necessity of residential mental health treatment services provided from 4/25/16 through 12/31/16 for management of this patients medical condition. There was no evidence that the patient had severe and persistent psychiatric symptoms that results in impairment in multiple settings that require active treatment in a 24-hour supervised setting. Further, there was no evidence of suicidal or homicidal ideations, no evidence of psychosis, and no evidence of physical aggression during this period of time. The documentation suggests the patient could have reasonably been treated at a less intrusive, less invasive level of care such as outpatient treatment. Given these findings, the residential mental health treatment services provided from 4/25/16 through 12/31/16 were not medically necessary. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that ClonoSEQ is a type of next-generation sequencing used to evaluate for minimal residual disease (MRD). It has been approved by the U.S. Food and Drug Administration (FDA) for MRD assessment in myeloma. A baseline sample is required to identify the dominant clonotype, but the study can be performed on both fresh and stored samples. It is not impacted by therapeutic monoclonal antibodies. The National Comprehensive Cancer Network (NCCN) guidelines recommend consideration of using MRD for monitoring patients. The patient has had two tests, the first in 2019 to establish a baseline and the most recent to evaluate response to current therapy. There is sufficient support for the services at issue in this setting. Therefore, unlisted laboratory services provided on 7/02/19 and 1/28/20 were likely to have been more beneficial than other methods of evaluating this patient.
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A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male who reported palpitations. He was evaluated with a 30-day event monitor which demonstrated an episode of atrial fibrillation lasting 30 seconds. The patients provider recommended an implantable loop recorder to assist with treatment planning given the risks of bleeding if anticoagulation was initiated. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient.
current syncope and has had negative results of external electrocardiogram monitoring. This patient was shown to have a 30-second episode of atrial fibrillation on the initial event monitor performed. | Upheld | Experimental | Summary Reviewer 2
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male who reported palpitations. He was evaluated with a 30-day event monitor which demonstrated an episode of atrial fibrillation lasting 30 seconds. The patients provider recommended an implantable loop recorder to assist with treatment planning given the risks of bleeding if anticoagulation was initiated. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. There is a lack of support for the device at issue in this patients case. The medical evidence does not support an implantable loop recorder for monitoring for atrial fibrillation burden in this clinical setting. The use of an implantable loop recorder is supported if the patient has had cryptogenic stroke or recurrent syncope and has had negative results of external electrocardiogram monitoring. This patient was shown to have a 30-second episode of atrial fibrillation on the initial event monitor performed. In sum, the implantable ambulatory event monitor provided on 12/28/17 was not likely to have been superior over other available methods of evaluating this patient. Based upon the information set forth above, the device at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 46-year-old female enrollee has requested authorization and coverage for breast reconstruction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who is status post breast implant placement.
the patient is status post bilateral augmentation mammaplasty for apparent aesthetic reasons. Following traumatic injury, she had significant shoulder pain and weakness related to a neuropathy. She has undergone reconstructive procedures in order to improve the function of her shoulder, as well as physical therapy. | Overturned | Medical Necessity | Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for breast reconstruction surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who is status post breast implant placement. The physician reviewer found the patient is status post bilateral augmentation mammaplasty for apparent aesthetic reasons. Following traumatic injury, she had significant shoulder pain and weakness related to a neuropathy. She has undergone reconstructive procedures in order to improve the function of her shoulder, as well as physical therapy. Multiple providers have recommended implant removal or breast reduction to allow for improved function. However, the plastic surgery recommendation is for reducing the implant size by 50 cc, performing a mastopexy, and placing a Xenograft. These procedures are not medically necessary. However, as the implant size of 350 cc may be contributing to her chronic pain and functional impairment, implant removal may provide improved relief given failure of other treatment. Therefore, as the patients functional impairment from a previous traumatic injury may improve with implant removal, removal of implants is medically indicated. No other surgical intervention would likely provide reasonable improvement. Therefore, a portion of the requested services is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
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A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. | Overturned | Experimental | Summary Reviewer 1
A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that currently, the U.S. Food and Drug Administration (FDA) requires all sperm donors, anonymous and directed, to be tested for human immunodeficiency virus (HIV), hepatitis B and hepatitis C, syphilis, human T-lymphotropic virus types I and II, cytomegalovirus, chlamydia trachomatis, and neisseria gonorrhea. Future infectious profile for the patient may differ from current profile at the time of the sperm donation. Hence the need to define the microbial profile of the patient at the time of the donation. Given that this patient has Ewing sarcoma and is undergoing chemotherapy, semen preservation is indicated. Thus, the HTLV testing performed on 4/25/16 was appropriate and likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 43-year-old male enrollee has requested reimbursement for Anser IFX testing performed on 8/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
This patient has had interrupted therapy with Remicade. He was failing all therapy and may require extensive surgery. Remicade was restarted, but he appeared to be having an immune response to therapy. | Overturned | Experimental | Summary Reviewer 1
A 43-year-old male enrollee has requested reimbursement for Anser IFX testing performed on 8/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. This patient has had interrupted therapy with Remicade. He was failing all therapy and may require extensive surgery. Remicade was restarted, but he appeared to be having an immune response to therapy. It was important to determine if there were antibodies as their presence will make further therapy futile. In sum, Anser IFX testing performed on 8/09/15 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested authorization and coverage for Saxenda Pen injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested authorization and coverage for Saxenda Pen injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that according to the guidelines from the Endocrine Society, diet, exercise, and behavioral modification should be included in all obesity management approaches for patients with body mass index greater than or equal to 25 kg/m2. For patients with a body mass index greater than or equal to 27 kg/m2 with comorbidity or a body mass index over 30 kg/m2, pharmacotherapy may be used as an adjunct to behavioral modification. Drugs may amplify adherence to behavior change and may improve physical functioning, such that increased physical activity is easier in those who cannot exercise initially. Patients who have a history of being unable to successfully lose and maintain weight and who meet label indications are candidates for weight loss medications. Saxenda (liraglutide) is a glucagon-like peptide-1 receptor agonist that has been successfully used in the treatment of type 2 diabetes for several years. Weight loss has been well-described as an additional benefit with liraglutide therapy, which prompted the manufacturer to evaluate and develop a higher dose formulation specifically for the treatment of obesity. Liraglutide 3 mg/day has been approved by the U.S. Food and Drug Administration for this indication. In this patients case, the records document a body mass index of 30.07 kg/m2. The current medical evidence supports the requested medication in this clinical setting. Therefore, Saxenda pen injector is medically necessary for the treatment of this patient. | 0 |
A 35-year-old male enrollee has requested authorization and coverage for HP Acthar Gel 80 units. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
In this case, the patient is unable to take traditional corticosteroids due to prior side effects. He has benefitted from Acthar gel. | Overturned | Medical Necessity | Summary Reviewer
A 35-year-old male enrollee has requested authorization and coverage for HP Acthar Gel 80 units. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Acthar gel has been approved by the U.S. Food and Drug Administration for multiple sclerosis relapses. In this case, the patient is unable to take traditional corticosteroids due to prior side effects. He has benefitted from Acthar gel. The medical evidence supports the requested medication in this clinical setting. Therefore, HP Acthar gel 80 unit/ml vial is medically necessary for the treatment of this patient. | 1 |
The patient is a 51-year-old female with chronic left knee pain. The patient has requested authorization and coverage for knee arthroscopy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
has evidence of degenerative changes in the left knee along with meniscocapsular separation, meniscal cyst, and tearing of both menisci. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 51-year-old female with chronic left knee pain. The patient has requested authorization and coverage for knee arthroscopy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that this patient has evidence of degenerative changes in the left knee along with meniscocapsular separation, meniscal cyst, and tearing of both menisci. Meniscocapsular separation is a lesion of the attachment of the peripheral section of the meniscus to the capsule and is less common than other meniscus injuries. Per Tiftikci and Serbest, a repair made with the all-inside method is successful clinically and functionally. In addition, it is recommended that the repair is made from the tibial surface, which does not change the anatomic position of the meniscus. A partial medial meniscectomy with removal of the unstable portions of the meniscus is recommended. | 1 |
A 63-year-old male enrollee has requested authorization and coverage for left total knee replacement. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees knee pain.
this patient has clinical and radiographic evidence of osteoarthritis of the left knee with a history of failed conservative treatment for over three years. | Overturned | Medical Necessity | Summary Reviewer
A 63-year-old male enrollee has requested authorization and coverage for left total knee replacement. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees knee pain. The physician reviewer found the records document that this patient has clinical and radiographic evidence of osteoarthritis of the left knee with a history of failed conservative treatment for over three years. The surgical criteria include pain, functional alteration, objective findings of deformity, loss of motion, radiological findings of osteoarthritis involving at least two compartments, and failure of conservative treatment. All of these indications have been well documented in this case. As such, the requested left total knee arthroplasty is medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested surgery is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
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